Stryker ยท 2 hours ago
Staff Quality Engineer, NPI
San Jose, CA
Full-time
Onsite
Senior Level, Lead/Staff
$114K/yr - $187K/yr
5+ years expStryker is a company that offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics, and Spine. The Staff NPI Quality Engineer will provide quality assurance support for New Product Introductions, ensuring compliance with regulations while driving product competitiveness through various quality strategies and collaboration with cross-functional teams.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
Drive quality strategies for inspection, testing, and supplier qualification during new product development
Ensure proper linkage between design inputs/outputs, process controls, and customer needs during design transfer
Develop inspection documents, validate test methods, and implement inspection strategies for NPI projects
Lead or support process validation activities (IQ/OQ/PQ), including protocol development and execution
Identify, audit, and onboard new suppliers, lead component and product qualification activities
Create and maintain process risk documentation per ISO 14971 for regulatory submissions
Investigate and close non-conformances and CAPAs related to new product development
Support creation of Device Master Records and training during production process transfer
Collaborate with cross-functional teams to ensure compliance with ISO 13485, FDA regulations, and internal quality systems
Promote a customer-centric quality culture and support internal/external audits
Qualification
Required
Bachelor's degree in engineering or related field
5+ years of experience in Quality Engineering within medical device or regulated industry
Strong knowledge of Design Control, Process Validation, Risk Management, and Supplier Quality
Familiarity with ISO 13485, ISO 14971, and FDA regulations
Excellent communication and leadership skills; ability to train and influence cross-functional teams
Preferred
Master's degree in relevant field desired
ASQ-CQE, CQA or equivalent course work/experience desired
Experience with electrical/electro-mechanical systems, electrical V&V (IEC 60601, EMC/EMI), automated test equipment (LabVIEW/TestStand), electrical DFMEA/PFMEA, PCBA supplier qualification, and relevant certifications
Experience with statistical rationale for validation, sterilization validation strategies, and post-launch monitoring
Advanced understanding of inspection strategies and test method validation
Benefits
Medical and prescription drug insurance
Dental insurance
Vision insurance
Critical illness insurance
Accident insurance
Hospital indemnity insurance
Personalized healthcare support
Wellbeing program
Tobacco cessation program
Health Savings Account (HSA)
Flexible Spending Accounts (FSAs)
401(k) plan
Employee Stock Purchase Plan (ESPP)
Basic life and AD&D insurance
Short-term disability insurance
Company
Stryker
Stryker is a medical technology company that offers products and services in orthopaedics.
10001+ employees
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 (82)
2024 (76)
2023 (63)
2022 (78)
2021 (57)
2020 (77)
Funding
Current Stage
Public CompanyTotal Funding
unknown1990-01-02IPO
Leadership Team
Kevin Lobo
Chief Executive Officer
Glenn S. Boehnlein
Chief Financial Officer and Vice President
Recent News
GlobeNewswire News Room
2025-02-11
Company data provided by crunchbase