Philips Principal Design Assurance Engineer 

United States, Minnesota 

634361477

Your role:

• Updating risk documents, component qualification, statistical analysis of data, design verification and process validation planning as well as quality system compliance.
• Ensure Risk Management is effective utilizing feedback from validation, field service, post market surveillance, manufacturing indicators, CAPAs, HHAs, etc. Familiarity with ISO 14971, Risk Management for medical devices.
• Actively evaluate projects for opportunities to improve performance or accelerate learning; continuously monitors risk and mitigates as appropriate.
• 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 assure specific quality levels.
• Experienced in component inspection and testing techniques; must be able to read and interpret blueprints.
• Provide critical review of design requirements, justifications, rationales, protocols, deviations, test methods and training requirements.
• Works with cross functional team to complete component qualification activities.
• Works with cross functional team to plan and conduct design verification and process validation activities.
• Participate in the development and results analysis of verification and validation plans and test protocols to qualify and validate new product designs and processes.
• Serve as a technical expert for problem investigations to guide root cause analysis and corrective action development.
• Works with cross functional team to plan and conduct Design Verification, Process Validation and Design Validation testing.
• May directly supervise one or more technicians or engineers.
• Reporting to the Design Assurance Manager,you will collaborate cross-functionally with R&D, NPI, NPD and Advanced Development.
• ThisHybrid, Plymouth, MN basedrole may require travel up to 10%.

You're the right fit if:

• You have a minimum of 8 years’ experience working within FDA regulated medical device environments, with a focus in design control/assurance, risk management, FMEA’s, PHA’s etc.
• You have successfully supported multiple new product development cycles,with a deep understandingof how to apply Design/Process Controls.
• You have extensive experience in vascular medical devices/ electromechanical systems (intravascular ultrasound, thrombectomy, catheter-based balloons, stents, or atherectomy devices).
• You’re able to lead a team in completing Risk Management activities (PHA, FMEAs, Risk Management Report, and compliance tables for IEC 60601).
• You have expert knowledge of 21 CFR part 820, ISO13485, ISO 14971 and IEC 60601.
• You have extensive experience in leading test method validation (TMV) activities.
• You’re able to specify Design, Use and/or Clinical FMEAs
• You have proven experience conducting Human Factors /Usability studies and testing.
• You’re able to recommend sampling plans, equipment requirements, measurement techniques and training requirements-based on risk.
• You have proven abilities in data/statistical analysis.
• You have a minimum of a Bachelor’s Degree in Engineering (required) Mechanical, Chemical, Electrical, Biomedical or similar disciplines.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this.
• US work authorization is a precondition of employment. The company
  will not
  consider candidates who require sponsorship for a work-authorized visa, now or in the future.
• Company relocation benefits
  will not
  be provided for this position. For this position, you must reside in
  or
  within commuting distance to Plymouth, MN.

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

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If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion .