Stryker ยท 2 days ago
Senior Engineer, Manufacturing Engineering
Irvine, CA
Full-time
Onsite
Mid, Senior Level
2+ years expStryker is a leading company in medical technology, and they are seeking a Senior Manufacturing Engineer to lead sustaining engineering activities for manufacturing medical devices. This role will focus on continuous improvement, troubleshooting production issues, and ensuring compliance with internal quality systems while collaborating with various teams to optimize processes and improve product quality.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
Lead and execute process validation activities, IQ/OQ/PQ, for manufacturing processes, equipment, and test methods to ensure continued compliance and product quality
Develop, author, review, and approve validation protocols, reports, and supporting manufacturing documentation meeting internal quality system requirements
Assess and implement revalidation strategies driven by process changes, non-conformances, CAPAs, production metric trends, or continuous improvement initiatives
Troubleshoot manufacturing production and equipment issues related to existing established processes and directly work with cross-functional team members to implement corrective actions
Directly support change management activities, which will include performing risk assessments and assessing the impact on validated processes and products, equipment, and material changes
Support and drive Quarantine Ticket (QT) and Non-conformance (NC) report dispositions and investigations
Support Kaizen and continuous improvement events
Participate in internal/external audits by providing validation expertise and general guidance on existing manufacturing processes
Mentor entry-level to junior engineers and provide technical guidance
Qualification
Required
Bachelor's degree in mechanical engineering, biomedical engineering, or a related discipline
Minimum 2 years of engineering experience
Preferred
Catheter and/or medical device
Proficiency in SolidWorks for creating and modifying production-released models and drawings
Experience designing manufacturing fixtures, gauges, and test setups
Understanding of design for manufacturing (DFM) principles to support yield improvements and manufacturing robustness
Capable of performing tolerance analysis and stack-ups
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 (105)
2024 (76)
2023 (63)
2022 (78)
2021 (57)
2020 (77)
Funding
Current Stage
Public CompanyTotal Funding
unknown1990-01-02IPO
Leadership Team
Kevin Lobo
Chair & CEO
Glenn S. Boehnlein
Chief Financial Officer and Vice President
Recent News
GlobeNewswire News Room
2025-02-11
Company data provided by crunchbase