Senior Design Assurance Engineer
About The Position
The Senior Design Assurance Engineer will play a critical role in support of the design controls process, with a focus on Sustaining and New product development (NPI) of Philips’ Image Guided Therapy Devices (IGTD). Your role: 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.
Requirements
- You have a 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) and strong Understanding of all aspects of the QMS related to Design/Process Controls.
- You have strong understanding of Medical Device QSR regulations/standards including ISO 13485, ISO 14971, 21CFR (803, 806, 820, etc.), MDD/ EU MDR.
- You’re able to analyze quality data and draw conclusions regarding trending, KPI’s etc.
- You have 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).
- You have the proven ability to cultivate and maintain strong relationships with team members and internal/external stakeholders.
- You have a minimum of a bachelor’s degree in Quality, Engineering (Mechanical, Chemical, Biomedical) or a related Scientific discipline (required).
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position .
Nice To Haves
- ASQ certifications (desired).
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.
Benefits
- Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
