Design Quality Engineer

Philips
Massachusetts
Workplace: OnsiteFull timeUSD 103,000 - 163,000 annuallyFunction: QA, Test & Release EngineeringExperience: 3+ yearsEducation: bachelorsSkills: []

Own design quality and risk management for Philips Image Guided Therapy products, ensuring quality plans are followed and supporting product complaint investigations. Contribute to design inputs and verification/validation, design transfer, and field performance by validating areas such as usability, reliability, safety, security, privacy, and manufacturability. Perform post-market data analysis, update risk management activities, and initiate CAPA/field actions when needed.

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FursaFursa
Philips
Philips
2 months ago

Design Quality Engineer

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI
Last checked: 27 days agoStatus: Live

Job Summary

Own design quality and risk management for Philips Image Guided Therapy products, ensuring quality plans are followed and supporting product complaint investigations. Contribute to design inputs and verification/validation, design transfer, and field performance by validating areas such as usability, reliability, safety, security, privacy, and manufacturability. Perform post-market data analysis, update risk management activities, and initiate CAPA/field actions when needed.
Location: Massachusetts
Workplace: Onsite
Employment Type: Full time
Job Function: QA, Test & Release Engineering
Seniority: Mid level

Key Responsibilities

  • •Ensure quality plans are followed with emphasis on sustaining and product complaint investigations.
  • •Provide input to design I/O, design V&V activities, design transfer, product realization, and field performance to meet design requirements.
  • •Validate design inputs including usability, reliability, safety, security, privacy, serviceability, sustainability, and costs.
  • •Perform routine risk management updates and provide input to risk management activities across the product/system lifecycle.
  • •Analyze post-market data to assess product quality performance and initiate CAPA/field actions when required.
Travel: Low travel

Pay and Benefits

Salary: USD 103,000 - 163,000 annually
Perks:Paid Leave401kHsaEquityLearning Budget

Key Requirements

  • •3+ years of experience in FDA-regulated medical device environments focused on Design Assurance, Sustaining, and Post Market Complaint investigations.
  • •Proven knowledge of Risk Management (ISO 14971), FMEA/DFMEA, Design Verification/Validation, root cause analysis, and defect management.
  • •Experience supporting design quality tools for defect prevention, design traceability, and Design for Reliability.
  • •Experience using Post Market Surveillance (PMS) insights/data analytics to drive continuous improvement across the product lifecycle.
  • •Bachelor’s degree in Quality, Engineering, or a related discipline (required).
Experience:3+ yearsMedical devicesFDA regulatedPost-marketQuality engineering
Education:Bachelor's
Tech Stack:FDAISO 14971FMEADFMEADesign VerificationDesign ValidationRoot Cause AnalysisPost Market Surveillance (PMS)CAPA

Eligibility

Work Authorization:Authorization required. Sponsorship not provided.

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