9 Pfizer jobs in Portage

Senior Staff, Software Quality Assurance Engineer

Stryker is seeking a Senior Staff Software Quality Assurance Engineer to support our Digital Robotics and Enabling Technologies business by driving quality processes. In this role, you will partner with R&D software development teams to guide them through internal quality system processes and ensure compliance with regulatory standards, including FDA, HIPAA, ISO, and SOC 2.

Work Flexibility:

Hybrid : Candidates must reside within a commutable distance to Portage, MI, or Weston, FL and be available to work onsite several times per week.

What you will do:

• Lead SOC 2 compliance activities and support internal and external audits.

• Define and update quality system software processes to ensure compliance with regulations related to change control, data privacy, software development, and security.

• Present product-related risks during design reviews and oversee mitigation throughout the product lifecycle.

• Influence new product development by defining design verification and validation test requirements to ensure compliance with design inputs and regulatory standards.

• Perform risk analyses and develop appropriate mitigation strategies.

• Collaborate with leadership and cross-functional teams to gather process requirements and drive continuous improvement.

• Conduct internal quality system audits and contribute to CAPA (Corrective and Preventive Action) initiatives.

• Work within Agile (Scrum)/DevOps environments using ALM tools for defect tracking, traceability, and release/build management.

What you will need:

Basic Qualifications:

• Bachelor's degree in Software Engineering, Computer Science, or a related field.

• 6+ years of experience in software development or quality engineering roles.

• Working knowledge of the Software Development Life Cycle (SDLC) and proficiency in Agile, Scrum, SAFe, and DevOps methodologies

• Experience with cloud platforms, preferably Microsoft Azure or AWS

• Knowledge of SOC 2, ISO, HIPAA, FDA, or other related regulatory standards

• Proficient in Agile, Scrum, SAFe, and DevOps software development methodologies.

• Solid understanding of quality systems, including CAPA, audits, and statistical analysis

Preferred Qualifications:

• Knowledge of AICPA SOC 2 certification requirements or equivalent standards.

• Familiarity with GAMP 5, Computer System Validation (CSV), and process validation

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

**Senior Staff, Software Quality Assurance Engineer**
Stryker is seeking a Senior Staff Software Quality Assurance Engineer to support our Digital Robotics and Enabling Technologies business by driving quality processes. In this role, you will partner with R&D software development teams to guide them through internal quality system processes and ensure compliance with regulatory standards, including FDA, HIPAA, ISO, and SOC 2.
**Work Flexibility:**
_Hybrid_ : Candidates must reside within a commutable distance to Portage, MI, or Weston, FL and be available to work onsite several times per week.
**What you will do:**
+ Lead SOC 2 compliance activities and support internal and external audits.
+ Define and update quality system software processes to ensure compliance with regulations related to change control, data privacy, software development, and security.
+ Present product-related risks during design reviews and oversee mitigation throughout the product lifecycle.
+ Influence new product development by defining design verification and validation test requirements to ensure compliance with design inputs and regulatory standards.
+ Perform risk analyses and develop appropriate mitigation strategies.
+ Collaborate with leadership and cross-functional teams to gather process requirements and drive continuous improvement.
+ Conduct internal quality system audits and contribute to CAPA (Corrective and Preventive Action) initiatives.
+ Work within Agile (Scrum)/DevOps environments using ALM tools for defect tracking, traceability, and release/build management.
**What you will need:**
Basic Qualifications:
+ Bachelor's degree in Software Engineering, Computer Science, or a related field.
+ 6+ years of experience in software development or quality engineering roles.
+ Working knowledge of the Software Development Life Cycle (SDLC) and proficiency in Agile, Scrum, SAFe, and DevOps methodologies
+ Experience with cloud platforms, preferably Microsoft Azure or AWS
+ Knowledge of SOC 2, ISO, HIPAA, FDA, or other related regulatory standards
+ Proficient in Agile, Scrum, SAFe, and DevOps software development methodologies.
+ Solid understanding of quality systems, including CAPA, audits, and statistical analysis
Preferred Qualifications:
+ Knowledge of AICPA SOC 2 certification requirements or equivalent standards.
+ Familiarity with GAMP 5, Computer System Validation (CSV), and process validation
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

**Position Overview**
At PNC, our people are our greatest differentiator and competitive advantage in the markets we serve. We are all united in delivering the best experience for our customers. We work together each day to foster an inclusive workplace culture where all of our employees feel respected, valued and have an opportunity to contribute to the company's success. As a Senior Quality Assurance Specialist within PNC's Lending Technology Credit Card Processing Rewards organization, you will be based in Pittsburgh, PA, Strongsville, OH or Kalamazoo, MI. The position is primarily based in a PNC location. Responsibilities require time in the office or in the field on a regular basis. Some responsibilities may be performed remotely, at the manager's discretion.
As a Senior Quality Assurance Specialist, you will be responsible for reviewing business requirements and translating them into testing requirements. Additionally, you will attend various project meetings, follow our application development topics, as well as provide input to testing requirements as the project progresses. Specific job duties may include the following:
-Test Planning & Strategy
-Develop, document, and maintain test plans, test cases, and test scripts based on business and technical requirements for both Java and mainframe applications.
-Collaborate with developers, business analysts, and project managers to define comprehensive test strategies for end-to-end solutions.
-Manual & Automated Testing
-Perform functional, regression, system, and integration testing for Java-based applications built using Spring Boot and REST APIs.
-Execute tests for mainframe systems, including COBOL-based applications and JCL job flows.
-Design and maintain automated test scripts using Selenium, JUnit, or TestNG for web and API testing or equivalent.
-Utilize RestAssured or Postman for validating RESTful services.
-Mainframe Test Execution
-Run and validate jobs on the mainframe.
-Knowledge of JCL in an MVS environment.
-Ability to understand job dependencies and requirements.
-Able to execute transactions in CICS.
-Use tools such as TSO/ISPF to navigate and test mainframe applications.
-Analyze and verify VSAM, DB2, or other data storage formats used in legacy systems.
-Data Validation & SQL Testing
-Create and execute complex SQL queries for validating backend data across Oracle and mainframe DB2 systems.
-Compare frontend outputs with backend data to ensure data integrity across applications.
-Test Automation & CI/CD Integration
-Integrate test suites into CI/CD pipelines using tools such as Jenkins, Git, and Bitbucket.
-Collaborate with DevOps teams to ensure automated test coverage is part of build and deployment workflows.
-Defect Management & Reporting
-Log, track, and manage defects using JIRA, ensuring clear documentation and prioritization.
-Work closely with development teams to troubleshoot, reproduce, and resolve defects quickly.
-Performance & Security Testing Support - Good to have but not compulsory.
-Assist in performance testing using JMeter or LoadRunner as needed.
-Agile Team Participation
-Actively participate in Agile ceremonies including sprint planning, daily stand-ups, retrospectives, and demos.
-Provide QA status updates and contribute to continuous improvement of QA processes.
-Cross-System Testing
-Conduct end-to-end testing across distributed Java applications and integrated mainframe systems.
-Validate batch processing flows, messaging systems (e.g., MQ Series, Kafka), and real-time API interactions.
-Documentation & Compliance
-Maintain comprehensive QA documentation to support audit and compliance requirements.
-Follow enterprise QA standards and contribute to the evolution of best practices within the QE organization.
Due to the nature of the position, we are seeking candidates with the following:
-Qualifications:
-ISTQB (International Software Testing Qualification Board) or similar QA (Quality Assurance) certification preferred.
-Strong understanding of QA best practices, test metrics, and quality standards.
-Proven ability to quickly learn new technologies and legacy systems.
Technical Skills:
-Hands-on experience testing Java-based applications.
-Experience with mainframe applications - familiarity with JCL, TSO/ISPF, COBOL, and DB2.
-Proficient in automation testing tools such as Selenium, TestNG, JUnit, or equivalent.
-Experience in API testing using Postman, SOAP UI, or RestAssured.
-Good understanding of CI/CD tools like Jenkins, Git, and Maven.
-Solid knowledge of SQL and experience querying relational databases.
Testing Methodologies:
-Strong understanding of Agile/Scrum, SDLC(Software Development Life Cycle), and STLC(Software Testing Life Cycle).
-Skilled in creating and executing test plans, test cases, and test automation scripts.
-Experience in various testing types: Unit, functional, regression, integration, system testing & UAT
PNC will not provide sponsorship for employment visas or participate in STEM OPT for this position.
**Job Description**
+ Leads and reports on reviews and tests of software systems and products to verify compliance with applicable specifications and standards.
+ Leads the effort to work with software developers to resolves issues of incompliance through system modification, reconfiguration or workarounds. Establishes objectives for testing cycles. Develops test scenarios for unit, process, function, integration and acceptance testing .
+ Leads the team in planning and estimating quality assurance support requirements for new products, new functions and new components. Leads audits and reviews .
+ Oversees and leads the efforts to monitor adherence to quality standards in the development, implementation and upkeep of software products. Monitors effectiveness of the assurance process and tools .
+ Oversees the tracking of quality assurance metrics such as defect density and open defect counts. Oversees team members responsible for testing and inspection of products to determine compliance with specifications .
PNC Employees take pride in our reputation and to continue building upon that we expect our employees to be:
+ **Customer Focused** - Knowledgeable of the values and practices that align customer needs and satisfaction as primary considerations in all business decisions and able to leverage that information in creating customized customer solutions.
+ **Managing Risk** - Assessing and effectively managing all of the risks associated with their business objectives and activities to ensure they adhere to and support PNC's Enterprise Risk Management Framework.
**Qualifications**
Successful candidates must demonstrate appropriate knowledge, skills, and abilities for a role. Listed below are skills, competencies, work experience, education, and required certifications/licensures needed to be successful in this position.
**Preferred Skills**
Agile Methodology, Analytical Thinking, Automated Test Scripts, Controls Testing, Corporate Governance, Mainframe Programming, Quality Assurance (QA), Quality Support, Selenium, Software Testing, Test Case Development, Usability Testing
**Competencies**
Accuracy and Attention to Detail, Analytical Thinking, Influencing, Process Management, Products and Services, Software Development Life Cycle, Software Quality Assurance And Testing, Technical Documentation Management
**Work Experience**
Roles at this level typically require a university / college degree, with 3+ years of relevant / direct industry experience. Certifications are often desired. In lieu of a degree, a comparable combination of education, job specific certification(s), and experience (including military service) may be considered.
**Education**
Bachelors
**Certifications**
No Required Certification(s)
**Licenses**
No Required License(s)
**Pay Transparency**
Base Salary: $55,000.00 - $98,000.00
Salaries may vary based on geographic location, market data and on individual skills, experience, and education. This role is incentive eligible with the payment based upon company, business and/or individual performance.
**Application Window**
Generally, this opening is expected to be posted for two business days from 04/30/2025, although it may be longer with business discretion.
**Benefits**
PNC offers a comprehensive range of benefits to help meet your needs now and in the future. Depending on your eligibility, options for full-time employees include: medical/prescription drug coverage (with a Health Savings Account feature), dental and vision options; employee and spouse/child life insurance; short and long-term disability protection; 401(k) with PNC match, pension and stock purchase plans; dependent care reimbursement account; back-up child/elder care; adoption, surrogacy, and doula reimbursement; educational assistance, including select programs fully paid; a robust wellness program with financial incentives.
In addition, PNC generally provides the following paid time off, depending on your eligibility: maternity and/or parental leave; up to 11 paid holidays each year; 8 occasional absence days each year, unless otherwise required by law; between 15 to 25 vacation days each year, depending on career level; and years of service.
To learn more about these and other programs, including benefits for full time and part-time employees, visit Your PNC Total Rewards ( .
**Disability Accommodations Statement**
If an accommodation is required to participate in the application process, please contact us via email at . Please include "accommodation request" in the subject line title and be sure to include your name, the job ID, and your preferred method of contact in the body of the email. Emails not related to accommodation requests will not receive responses. Applicants may also call and say "Workday" for accommodation assistance. All information provided will be kept confidential and will be used only to the extent required to provide needed reasonable accommodations.
At PNC we foster an inclusive and accessible workplace. We provide reasonable accommodations to employment applicants and qualified individuals with a disability who need an accommodation to perform the essential functions of their positions.
**Equal Employment Opportunity (EEO)**
PNC provides equal employment opportunity to qualified persons regardless of race, color, sex, religion, national origin, age, sexual orientation, gender identity, disability, veteran status, or other categories protected by law.
This position is subject to the requirements of Section 19 of the Federal Deposit Insurance Act (FDIA) and, for any registered role, the Secure and Fair Enforcement for Mortgage Licensing Act of 2008 (SAFE Act) and/or the Financial Industry Regulatory Authority (FINRA), which prohibit the hiring of individuals with certain criminal history.
**California Residents**
Refer to the California Consumer Privacy Act Privacy Notice ( to gain understanding of how PNC may use or disclose your personal information in our hiring practices.

Be a part of a global team where what we do matters! At Epredia, we recognize that our talented employees are vital to our success. Our team is dedicated, our work is rewarding - both personally and professionally - because what we do matters?
We seek talented individuals who will contribute to and thrive in our collaborative, diverse, fast-paced environment while demonstrating a commitment to our core values, People, Customer, Results, Continuous Learning, and Innovation?
People - We win as a team?
Customer - We deliver customer-centric solutions?
Continuous Learning - We learn and always aim to be better?
Innovation - We innovate every day?
Results - Results matter for all of us.
We are seeking a skilled and motivated Quality Assurance Laboratory Technician II - Histochemistry/Chemistry with expertise in Histology and Chemistry to join our Epredia team. As a Quality Assurance Laboratory Technician II - Histochemistry/Chemistry, you will play a critical role in ensuring the quality and accuracy of our products through meticulous analysis, testing, and documentation. Your proficiency in histological techniques and chemical analysis will contribute to maintaining our high standards of product excellence and regulatory compliance.
Location: Onsite Kalamazoo, MI
What you will be doing:
+ Analyze chemical raw material samples.
+ Analyze chemical bulk solution and finished goods samples.
+ Maintain laboratory records (data integrity).
+ Maintain laboratory histology instruments.
+ Maintain a clean working environment.
+ Perform laboratory and manufacturing instrument calibrations
+ Initiate, revise and implement instrument and test method validation.
+ Review and write/revise laboratory SOP's on a continuous basis.
+ Analysis of customer complaints including written report.
+ Perform product stability testing/studies
+ Complete project work as to support the organization (including sustaining engineering work)
+ Participate in formulation development
+ Participate in review of risk analysis for product development
+ Lead and participate on Practical Process Improvement teams.
+ Responsible for performing tasks to support the quality system and quality policy as directed by QA/RA management.
+ Familiarity with Quality Systems regulations.
Skills you will need:
+ 3+ years of relevant work experience
+ Associates degree
+ Histologist Certification (HT) preferred
+ Experience supporting a manufacturing environment
+ Must be willing to work with and around hazardous chemicals.
+ Experience of working with FDA-regulated products desired (Medical Device/IVD preferred) (pharmaceutical, dietary supplement or food experience is acceptable).
+ Knowledge of ISO13485 / FDA QSR 21 CFR Part 820 / 803 requirements preferred, 21 CFR Part 110, 111 or 211 is acceptable.
+ Must demonstrate strong organizational skills and be able to handle multiple assignments simultaneously
+ Less than 5% travel (US & International)
+ 3+ years laboratory experience in an FDA-regulated laboratory
+ Proficient in MS applications (Excel, Word, Outlook)
#LI-MK1
TO ALL RECRUITMENT AGENCIES: Epredia does not accept unsolicited third-party resumes.
Building an Inclusive Culture: We are a company that brings the best people together and leverages their varying backgrounds, ideas, and points of view to invent on behalf of all customers. We are committed to equal employment opportunity for all individuals, without regard to race, color, national origin, ancestry, sex, age, religion, physical or mental disability, medical condition, veteran status, marital status, pregnancy, sexual orientation, gender identity, genetic information or any other protected classes which may exist under applicable federal, state or local law.
At Epredia, we improve lives by enabling better cancer diagnostics. We are a team of talented individuals with diverse backgrounds and expertise, working together to develop precision diagnostic solutions for our customers. We are a fast growing global company that drives innovation in diagnostics to create better outcomes for patients. Joining Epredia is much more than a job- it is an opportunity to be part of something with a purpose. Find out how you can improve lives while advancing your career.

Ascensia Diabetes Care is a global specialist diabetes care company, dedicated to helping people living with diabetes. Our mission is to empower people living with diabetes through innovative solutions that simplify and improve their lives. We use our innovation and specialist expertise in diabetes to develop high quality solutions and tools that make a positive, daily difference for people.
At Ascensia, our values serve as the bedrock of our organization. They guide our decisions, actions, and interactions, shaping the culture we collectively foster.
Our Values include:
+ Resilient Growth Mindset
+ Executional Excellence
+ Courageous Leadership
+ Inclusive Collaboration
We believe that when we live our values authentically, both individually and as a team, we unlock our true potential and drive sustainable success.
We are seeking a skilled and motivated Quality Assurance Laboratory Technician II - Histochemistry/Chemistry with expertise in Histology and Chemistry to join our Epredia team. As a Quality Assurance Laboratory Technician II - Histochemistry/Chemistry, you will play a critical role in ensuring the quality and accuracy of our products through meticulous analysis, testing, and documentation. Your proficiency in histological techniques and chemical analysis will contribute to maintaining our high standards of product excellence and regulatory compliance.
Location: Onsite Kalamazoo, MI
What you will be doing:
+ Analyze chemical raw material samples.
+ Analyze chemical bulk solution and finished goods samples.
+ Maintain laboratory records (data integrity).
+ Maintain laboratory histology instruments.
+ Maintain a clean working environment.
+ Perform laboratory and manufacturing instrument calibrations
+ Initiate, revise and implement instrument and test method validation.
+ Review and write/revise laboratory SOP's on a continuous basis.
+ Analysis of customer complaints including written report.
+ Perform product stability testing/studies
+ Complete project work as to support the organization (including sustaining engineering work)
+ Participate in formulation development
+ Participate in review of risk analysis for product development
+ Lead and participate on Practical Process Improvement teams.
+ Responsible for performing tasks to support the quality system and quality policy as directed by QA/RA management.
+ Familiarity with Quality Systems regulations.
Skills you will need:
+ 3+ years of relevant work experience
+ Associates degree
+ Histologist Certification (HT) preferred
+ Experience supporting a manufacturing environment
+ Must be willing to work with and around hazardous chemicals.
+ Experience of working with FDA-regulated products desired (Medical Device/IVD preferred) (pharmaceutical, dietary supplement or food experience is acceptable).
+ Knowledge of ISO13485 / FDA QSR 21 CFR Part 820 / 803 requirements preferred, 21 CFR Part 110, 111 or 211 is acceptable.
+ Must demonstrate strong organizational skills and be able to handle multiple assignments simultaneously
+ Less than 5% travel (US & International)
+ 3+ years laboratory experience in an FDA-regulated laboratory
+ Proficient in MS applications (Excel, Word, Outlook)
#LI-MK1
TO ALL RECRUITMENT AGENCIES: Ascensia does not accept unsolicited third-party resumes.
Building an Inclusive Culture: We are a company that brings varying backgrounds, ideas, and points of view to inventing on behalf of all customers. Our diverse perspectives are enriched by many dimensions, including race, ethnicity, gender, age, physical and mental ability, sexual orientation, religious beliefs, culture, language, and education, as well as professional and life experience. We are committed to diversity, equity, and inclusion, and leveraging our unique perspectives to scale our impact and growth.

Stryker is hiring a Staff Software Quality Engineer, Design Assurance to support our Medical's Digital Health division and portfolio Software as a Medical Device (SiMD) or Software in a Medical Device (SiMD) to execute on Digital Health projects as a software design quality assurance engineer for pre-market new product development projects.

Workplace Flexibility & Location requirements: This is a hybrid role requiring the candidate to be within commuting distance of one of the following locations: San Jose, CA; Orlando, FL; Portage, MI; or Fort Wayne, IN. The work schedule is structured to support flexibility, with in-office presence required Monday through Wednesday and remote work available on Thursday and Friday. To qualify, candidates must be able to commute to one of these specific facilities as needed.

What you will do:

• Execute quality assurance activities for new product development within Stryker's global Digital Health Portfolio, focusing on Acute Care in the Medical Division.

• Collaborate on software design, development, and validation strategies, ensuring alignment with Quality Management Systems compliance requirements.

• Partner with cross-functional teams, including marketing, R&D, clinical, regulatory, and operations, to deliver quality, compliant products.

• Oversee risk management using ISO14971 standards to ensure product safety, including defining critical quality attributes, assessing residual risks, and presenting risk/benefit justifications to executive leadership.

• Drive continuous improvement across the software lifecycle by implementing software industry best practices and regulatory standards (FDA, TGA, EUMDR, IT).

• Engage in design and development activities for both medical and non-medical software, including SaMD, MDDS, and AI/ML solutions.

• Implement standard development practices, promoting methodologies like SAFe for mobile and cloud-based solutions to enhance efficiency and compliance.

• Ensure cybersecurity, data privacy, and interoperability are integrated into digital product design, reviewing software artifacts for compliance and traceability.

What you need:

Required:

• Bachelor's degree in Science, Engineering or related discipline.

• Minimum of 4 years of experience working in a highly regulated industry in following cGMP and GDP regulations in the areas of Research & Development (R&D), Quality (QA/QC), or Systems Engineering.

• Experience working through software lifecycle processes (Agile SAFe/Waterfall)?

• Experience with software Failure Modes Effect Analysis (sFMEA), Security Risk Assessments and defect management, software testing and/or verification/validation.

Preferred:

• Bachelor's degree in Computer Engineering, Electrical Engineering, Software Engineering, or Computer Science.

• Experience with regulatory agencies (FDA, MoH, TUV) and medical device regulations (820, IEC 62304/82304, 60601), with experience in Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), and/or Digital Health Systems and Telehealth Solutions.

• Experience with software technologies for mobile, cloud, and AI/ML solutions, including Amazon AWS, Microsoft Azure, Apple, or Android platforms

• Experience in programming languages including C#, Python, Kotlin, Java, or TypeScript.

87,600.00 to 186,700.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

Stryker is hiring a Staff Software Quality Engineer, Design Assurance to support our Medicals Digital Health division and portfolio Software as a Medical Device (SiMD) or Software in a Medical Device (SiMD) to execute on Digital Health projects as a software design quality assurance engineer for pre-market new product development projects.

Workplace Flexibility & Location requirements: This is a hybrid role requiring the candidate to be within commuting distance of one of the following locations: San Jose, CA; Orlando, FL; Portage, MI; or Fort Wayne, IN. The work schedule is structured to support flexibility, with in-office presence required Monday through Wednesday and remote work available on Thursday and Friday. To qualify, candidates must be able to commute to one of these specific facilities as needed.

What you will do:

• Execute quality assurance activities for new product development within Stryker's global Digital Health Portfolio, focusing on Acute Care in the Medical Division.

• Collaborate on software design, development, and validation strategies, ensuring alignment with Quality Management Systems compliance requirements.

• Partner with cross-functional teams, including marketing, R&D, clinical, regulatory, and operations, to deliver quality, compliant products.

• Oversee risk management using ISO14971 standards to ensure product safety, including defining critical quality attributes, assessing residual risks, and presenting risk/benefit justifications to executive leadership.

• Drive continuous improvement across the software lifecycle by implementing software industry best practices and regulatory standards (FDA, TGA, EUMDR, IT).

• Engage in design and development activities for both medical and non-medical software, including SaMD, MDDS, and AI/ML solutions.

• Implement standard development practices, promoting methodologies like SAFe for mobile and cloud-based solutions to enhance efficiency and compliance.

• Ensure cybersecurity, data privacy, and interoperability are integrated into digital product design, reviewing software artifacts for compliance and traceability.

What you need:

Required:

• Bachelors degree in Science, Engineering or related discipline.

• Minimum of 4 years of experience working in a highly regulated industry in following cGMP and GDP regulations in the areas of Research & Development (R&D), Quality (QA/QC), or Systems Engineering.

• Experience working through software lifecycle processes (Agile SAFe/Waterfall).

• Experience with software Failure Modes Effect Analysis (sFMEA), Security Risk Assessments and defect management, software testing and/or verification/validation.

Preferred:

• Bachelors degree in Computer Engineering, Electrical Engineering, Software Engineering, or Computer Science.

• Experience with regulatory agencies (FDA, MoH, TUV) and medical device regulations (820, IEC 62304/82304, 60601), with experience in Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), and/or Digital Health Systems and Telehealth Solutions.

• Experience with software technologies for mobile, cloud, and AI/ML solutions, including Amazon AWS, Microsoft Azure, Apple, or Android platforms

• Experience in programming languages including C#, Python, Kotlin, Java, or TypeScript.

87,600.00 to 186,700.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location.Individual pay is based on skills, experience, and other relevant factors.

#J-18808-Ljbffr

**Stryker** is hiring a **Staff Software Quality Engineer, Design Assurance** to support our Medical's Digital Health division and portfolio Software as a Medical Device (SiMD) or Software in a Medical Device (SiMD) to execute on Digital Health projects as a software design quality assurance engineer for pre-market new product development projects.
**Workplace Flexibility & Location requirements:** This is a hybrid role requiring the candidate to be within commuting distance of one of the following locations: San Jose, CA; Orlando, FL; Portage, MI; or Fort Wayne, IN. The work schedule is structured to support flexibility, with in-office presence required Monday through Wednesday and remote work available on Thursday and Friday. To qualify, candidates must be able to commute to one of these specific facilities as needed.
**What you will do:**
+ Execute quality assurance activities for new product development within Stryker's global Digital Health Portfolio, focusing on Acute Care in the Medical Division.
+ Collaborate on software design, development, and validation strategies, ensuring alignment with Quality Management Systems compliance requirements.
+ Partner with cross-functional teams, including marketing, R&D, clinical, regulatory, and operations, to deliver quality, compliant products.
+ Oversee risk management using ISO14971 standards to ensure product safety, including defining critical quality attributes, assessing residual risks, and presenting risk/benefit justifications to executive leadership.
+ Drive continuous improvement across the software lifecycle by implementing software industry best practices and regulatory standards (FDA, TGA, EUMDR, IT).
+ Engage in design and development activities for both medical and non-medical software, including SaMD, MDDS, and AI/ML solutions.
+ Implement standard development practices, promoting methodologies like SAFe for mobile and cloud-based solutions to enhance efficiency and compliance.
+ Ensure cybersecurity, data privacy, and interoperability are integrated into digital product design, reviewing software artifacts for compliance and traceability.
**What you need:**
**Required:**
+ Bachelor's degree in Science, Engineering or related discipline.
+ Minimum of 4 years of experience working in a highly regulated industry in following cGMP and GDP regulations in the areas of Research & Development (R&D), Quality (QA/QC), or Systems Engineering.
+ Experience working through software lifecycle processes (Agile SAFe/Waterfall)?
+ Experience with software Failure Modes Effect Analysis (sFMEA), Security Risk Assessments and defect management, software testing and/or verification/validation.
**Preferred:**
+ Bachelor's degree in Computer Engineering, Electrical Engineering, Software Engineering, or Computer Science.
+ Experience with regulatory agencies (FDA, MoH, TUV) and medical device regulations (820, IEC 62304/82304, 60601), with experience in Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), and/or Digital Health Systems and Telehealth Solutions.
+ Experience with software technologies for mobile, cloud, and AI/ML solutions, including Amazon AWS, Microsoft Azure, Apple, or Android platforms
+ Experience in programming languages including C#, Python, Kotlin, Java, or TypeScript.
87,600.00 to 186,700.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.