Grove Technical Resources, INC · 3 weeks ago
Sr. Design Quality Engineer – Medical Device
Los Angeles, CA
Contract
Onsite
Senior Level
5+ years expGrove Technical Resources, INC is seeking an experienced Senior Design Quality Engineer to support the full product development lifecycle for implantable and electro-mechanical medical devices. The ideal candidate will ensure compliance with FDA and ISO standards while managing Design Controls, Risk Management, and Validation processes.
ConsultingHuman ResourcesRecruiting
Hiring Manager
Sudheer D
Responsibilities
Support the full product development lifecycle for implantable and electro-mechanical medical devices
Ensure compliance with FDA 21 CFR 820, ISO 13485, ISO 14971, and EU-MDR standards
Manage Design Controls, Risk Management (FMEA, Hazard Analysis), and Validation (TMV, IQ/OQ/PQ)
Conduct Design Verification & Validation Testing
Oversee Process Validation (TMV, IQ/OQ/PQ)
Handle Supplier Qualification & Design Transfer
Engage in Problem Solving / CAPA / Continuous Improvement
Qualification
Required
Strong expertise in Design Controls
Strong expertise in Risk Management (FMEA, Hazard Analysis)
Strong expertise in Validation (TMV, IQ/OQ/PQ)
Compliance with FDA 21 CFR 820
Compliance with ISO 13485
Compliance with ISO 14971
Compliance with EU-MDR standards
Design Control & Regulatory Compliance (ISO 13485, 21 CFR 820, EU-MDR)
Risk Management (FMEA, Hazard Analysis)
Electro-mechanical
Design Verification & Validation Testing
Process Validation (TMV, IQ/OQ/PQ)
Supplier Qualification & Design Transfer
Problem Solving / CAPA / Continuous Improvement
Bachelor's in Engineering/Science with 5+ years, or Master's with 3+ years in Quality/Engineering
Preferred
Experience with IEC 62304 and IEC 60601-1
ASQ Certification (Quality/Reliability)
Strong communication & documentation skills
Company
Grove Technical Resources, INC
Established in 2005, Grove Technical Resources has been at the forefront for providing exceptional services in the medical device industry.
11-50 employees
H1B Sponsorship
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2025 (11)
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Funding
Current Stage
Early StageCompany data provided by crunchbase