Staff Software Design Quality Engineer

Stryker Corporation•Portage, MI

54d•Hybrid

About The Position

Stryker is hiring a Staff Software Design Quality Engineer 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.

Requirements

Bachelor's degree in a science or engineering.
Minimum of 4 years of experience working in a highly regulated industry in the areas of Research & Development (R&D), Quality (QA/QC), Software Engineering, Information Technology, Healthcare IT 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 verification/validation.

Nice To Haves

Bachelor's degree in Computer Engineering, Electrical Engineering, Software Engineering, or Computer Science.
Previous employment at leading technology companies such as Amazon, Google, Microsoft, or similar, demonstrating strong technical skills
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
Cybersecurity certification (e.g., CISSP, Security+, or equivalent) or demonstrated experience in secure software development, with a strong foundation in risk management methodologies and the creation and maintenance of detailed Failure Modes and Effects Analyses (FMEAs).

Responsibilities

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 documentation aligns 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.

Benefits

salary plus bonus eligible + benefits
Individual pay is based on skills, experience, and other relevant factors.
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 Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.

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