Senior Design Assurance Engineer

Philips
United States
Workplace: OnsiteFull timeFunction: Design (Product/UX/UI/Visual)Experience: 5+ yearsEducation: bachelorsSkills: ["Analytical","Communication","Collaboration","Problem-solving","Leadership"]

Senior Design Assurance Engineer supporting Sustaining and New Product Development for Philips Image Guided Therapy Devices. You will manage risk, QA documentation, design verification and process validation, V&V planning, and cross-functional collaboration while ensuring compliance with ISO 14971, ISO 13485, and FDA regulations. This office-based role in Plymouth, MN may require travel up to 10%.

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Philips
Philips
6 months ago

Senior Design Assurance Engineer

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Source: Company careers pageValidated by: Fursa AI
Last checked: 17 hours agoStatus: Live

Job Summary

Senior Design Assurance Engineer supporting Sustaining and New Product Development for Philips Image Guided Therapy Devices. You will manage risk, QA documentation, design verification and process validation, V&V planning, and cross-functional collaboration while ensuring compliance with ISO 14971, ISO 13485, and FDA regulations. This office-based role in Plymouth, MN may require travel up to 10%.
Location: United States
Workplace: Onsite
Employment Type: Full time
Job Function: Design (Product/UX/UI/Visual)
Seniority: Sr. Manager level

Key Responsibilities

  • •Ensure risk management is effective using validation feedback, post-market surveillance, CAPAs, HHAs, and updating risk documents and qualification data as well as quality system compliance.
  • •Provide critical quality review of design requirement rationales, test methods, training requirements, and test method validation requirements.
  • •Determine sampling plans, equipment needs, measurement techniques, and training requirements to meet specified quality levels.
  • •Collaborate with cross-functional teams to complete component qualification activities and plan/conduct design verification and process validation activities.
  • •Contribute to development and analysis of verification and validation plans and test protocols to qualify and validate new product designs and processes.
Travel: Low travel

Pay and Benefits

Perks:401kHsaEquityPaid Leave

Key Requirements

  • •Minimum of 5+ years’ experience in FDA-regulated medical device environments with a focus on Design Assurance/Control and knowledge of Risk Management (ISO 14971) and QMS related to Design/Process Controls
Experience:5+ yearsMedical devicesFDA regulatedQuality & Regulatory
Education:Bachelor's
Skills:AnalyticalCommunicationCollaborationProblem-solvingLeadership
Certifications:ASQ (desired)
Tech Stack:ISO 13485ISO 1497121 CFR 803/806/820MDDEU MDRDVTDVV

Company Brief

Philips
Global health technology company focusing on diagnostic imaging, patient monitoring, and consumer health products. Philips develops medical devices, healthcare informatics, and solutions to improve patient care and personal well-being.
Industry: HealthTech
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Amsterdam, Netherlands
Founded: 1891
Glassdoor
Glassdoor: 3.8
WebsiteLinkedIn