Senior Staff, Software Quality Assurance Engineer
49024 Portage, Michigan
Stryker
Posted 15 days ago
Job Viewed
Job Description
**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 internal procedures and regulatory standards (e.g SOC 2, ISO, FDA and HIPAA)
**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:**
+ Support software product teams by guiding them through internal quality processes and documentation requirements.
+ Participate in risk assessments, quality document reviews, design review and change control processes to ensure quality impacts are considered and addressed.
+ Ensure development activities align with applicable regulatory and compliance frameworks (e.g., SOC 2, ISO 27001, FDA 21 CFR Part 11, HIPAA, ISO 13485).
+ Lead SOC 2 compliance activities and support internal and external audits.
+ Support internal and external SOC2 audits
+ Ensure that cloud system validation and software lifecycle deliverables meet applicable standards and company policies.
+ Collaborate with leadership and cross-functional teams to identify process gaps and implement continuous improvements across the SDLC
+ Maintain and improve quality system documentation, including SOPs, work instructions and guidance documents.
**What you will need:**
Basic Qualifications:
+ Bachelor's degree in Software Engineering, Computer Science, or a related field.
+ 6+ years of experience in software quality or quality systems role, ideally supporting cloud-based or SaaS products.
+ Strong understanding of software development lifecycles (SDLC) and how quality assurance fits into each stage
+ Experience with cloud platforms, preferably Microsoft Azure or AWS
+ Knowledge of SOC 2, ISO, HIPAA, FDA, or other related regulatory standards
+ Solid understanding of quality systems, audits, software change control and statistical analysis
Preferred Qualifications:
+ Knowledge of AICPA SOC 2 certification requirements or equivalent standards.
+ Certifications such as Software Quality Engineer (CSQE) or equivalent.
+ Experience with the medical device product development lifecycle.
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 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 internal procedures and regulatory standards (e.g SOC 2, ISO, FDA and HIPAA)
**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:**
+ Support software product teams by guiding them through internal quality processes and documentation requirements.
+ Participate in risk assessments, quality document reviews, design review and change control processes to ensure quality impacts are considered and addressed.
+ Ensure development activities align with applicable regulatory and compliance frameworks (e.g., SOC 2, ISO 27001, FDA 21 CFR Part 11, HIPAA, ISO 13485).
+ Lead SOC 2 compliance activities and support internal and external audits.
+ Support internal and external SOC2 audits
+ Ensure that cloud system validation and software lifecycle deliverables meet applicable standards and company policies.
+ Collaborate with leadership and cross-functional teams to identify process gaps and implement continuous improvements across the SDLC
+ Maintain and improve quality system documentation, including SOPs, work instructions and guidance documents.
**What you will need:**
Basic Qualifications:
+ Bachelor's degree in Software Engineering, Computer Science, or a related field.
+ 6+ years of experience in software quality or quality systems role, ideally supporting cloud-based or SaaS products.
+ Strong understanding of software development lifecycles (SDLC) and how quality assurance fits into each stage
+ Experience with cloud platforms, preferably Microsoft Azure or AWS
+ Knowledge of SOC 2, ISO, HIPAA, FDA, or other related regulatory standards
+ Solid understanding of quality systems, audits, software change control and statistical analysis
Preferred Qualifications:
+ Knowledge of AICPA SOC 2 certification requirements or equivalent standards.
+ Certifications such as Software Quality Engineer (CSQE) or equivalent.
+ Experience with the medical device product development lifecycle.
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.
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0
Staff Software Quality Engineer, Design Assurance
49024 Portage, Michigan
Stryker
Posted 15 days ago
Job Viewed
Job Description
**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.
**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.
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