Philips · 2 months ago
Senior Design Assurance Engineer
Plymouth
Full-time
Onsite
Senior Level
$91K/yr - $146K/yr
5+ years expPhilips is a health technology company committed to improving healthcare access and quality for everyone. The Senior Design Assurance Engineer will support the design controls process for Image Guided Therapy Devices, ensuring effective risk management and quality compliance throughout product development.
B2BConsumer ElectronicsElectronicsLightingWellness
No H1B
U.S. Citizen Only
Responsibilities
Ensures Risk Management is effective utilizing feedback from validation, field service, post market surveillance, manufacturing indicators, CAPAs, HHAs, and updating risk documents, component qualification, statistical analysis of data, design verification and process validation planning as well as quality system compliance
Provides critical quality review of design requirement rationales, test methods, training requirements and test method validation requirements
Determines and recommends sampling plans, equipment requirements, measurement techniques and training requirements that will ensure specific quality levels
Works with cross functional teams to complete component qualification activities, plan/conduct design verification (DVT) and process validation activities
Participates in the development/results analysis of verification and validation (V&V) plans and test protocols to qualify and validate new product designs and processes
Qualification
Required
Minimum of 5+ years' experience in FDA regulated medical device environments, with a focus on Design Assurance/Control
Detailed knowledge of Risk Management (ISO 14971)
Strong understanding of all aspects of the QMS related to Design/Process Controls
Strong understanding of Medical Device QSR regulations/standards including ISO 13485, ISO 14971, 21CFR (803, 806, 820, etc.), MDD/ EU MDR
Ability to analyze quality data and draw conclusions regarding trending, KPI's etc
Extensive experience supporting the creation and review of all medical device documentation including- Component qualification, Design Verification Test/regression plans, test protocols/reports, process validation, issue tracking/resolution and auditing Design History Files (DHF)
Proven ability to cultivate and maintain strong relationships with team members and internal/external stakeholders
Minimum of a bachelor's degree in Quality, Engineering (Mechanical, Chemical, Biomedical) or a related Scientific discipline
Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation
Preferred
ASQ certifications (desired)
Benefits
Generous PTO
401k (up to 7% match)
HSA (with company contribution)
Stock purchase plan
Education reimbursement
Company
Philips
Philips is a technology company that operates in various fields, including healthcare, consumer electronics, lighting, and home appliances.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$4.23BKey Investors
EXOR N.V.Bill & Melinda Gates FoundationInnovative Health Initiative
2025-03-19Post Ipo Equity
2024-05-23Post Ipo Debt· $756.82M
2023-11-07Grant· $44.6M
Leadership Team
Neil Mesher
CEO and SVP, UK and Ireland
Recent News
2026-01-06
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