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The Principal Design Assurance Engineer will serve a critical role in completing relevant Design Assurance activities on new Image Guided Therapy Device product development projects, ensuring overall project and business objectives.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.
This Hybrid , Plymouth, MN based role 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 understanding of 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 position .
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.
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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 here.#LI-PH1It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.Equal Employment and Opportunity Employer/Disabled/Veteran
