Stryker · 5 hours ago
Senior Design Quality Engineer (Hybrid)
Stryker is a leading company in the medical device industry, and they are seeking a Senior Design Quality Engineer to ensure their innovative products meet high safety and performance standards. The role involves partnering with cross-functional teams, leading product safety risk management activities, and driving quality improvements throughout the product development lifecycle.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
Partner with cross-functional teams to integrate quality requirements into new product development processes
Lead product safety risk management activities, including hazard analysis, DFMEA, and risk assessments for distributed products
Develop and approve validation strategies, plans, protocols, and reports to ensure compliance with design validation policies
Optimize test plans, methods, and sampling strategies to meet regulatory and quality standards
Establish and monitor field performance metrics post-launch; analyze trends and recommend improvements
Drive timely resolution of quality issues, serving as a key contributor in CAPA investigations and risk management activities
Participate in internal and external audits, providing expertise on design controls and product development processes
Lead initiatives to improve quality systems and processes across the organization
Qualification
Required
Bachelor's degree in Engineering, Science, or a related field
2+ years of experience in a highly regulated environment (quality, manufacturing, or engineering)
Demonstrated experience contributing to a design development project
Preferred
Bachelor's degree in Biomedical Engineering
Prior experience with electromechanical design and embedded software in product development
Knowledge of medical device industry regulations and standards
Familiarity with quality tools such as root cause analysis, sampling plans, and validation testing
Understanding of good design practices, specification development, and industry standards
Benefits
Bonus eligible
Benefits
Company
Stryker
Stryker is a medical technology company that offers products and services in orthopaedics.
H1B Sponsorship
Stryker has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (105)
2024 (76)
2023 (63)
2022 (78)
2021 (57)
2020 (77)
Funding
Current Stage
Public CompanyTotal Funding
unknown1990-01-02IPO
Recent News
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2025-02-11
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