Senior Staff Software Design Quality Engineer

Work Flexibility: Hybrid or Onsite

Stryker is hiring a Senior Staff Software Design Quality Engineer to support our Medical’s Digital Health division and portfolio (Software as a Medical Device/Telehealth) to execute on Digital Health (Software as a Medical Device/Telehealth) 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. Relocation assistance is approved for eligible candidates.

What you will do:

• Lead quality assurance efforts 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 or an engineering discipline.

• Minimum of 6 years of experience in a regulated industry, preferably within the medical device sector, in roles such as R&D, Quality, or Systems Engineering.

• Demonstrated knowledge and experience working through software lifecycle processes (Agile SAFe/Waterfall).  

• Demonstrated applied knowledge of software Failure Modes Effect Analysis (sFMEA), Security Risk Assessments and Risk assessments.

Preferred:

• Experience with medical device product development lifecycle, including risk management and design/process verification and validation.

• Demonstrated experience working with software development R&D teams leveraging processes such as SAFe or Agile.

• Knowledge of software design and development, release management, defect management and testing tools and processes. (Bitbucket/Github/Jira/Confluence).

• Knowledge of software technologies for mobile, cloud and AI/ML solutions. (Amazon AWS/Microsoft Azure/Apple/Android etc.)

• Thorough knowledge and understanding of US and International Medical Device Regulations (820/IEC 62304/IEC82304/60601)

• Demonstrated experience participating in both internal and external audits.

112,800.00 to 239,900.00 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.