Philips

Senior Design Quality Engineer – Products & Systems

Philips

full-time

Posted on:

Location Type: Hybrid

Location: Pune • India

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Job Level

Senior

About the role

  • Lead on setting Quality and Reliability targets for IGT Systems medical products
  • Provide coaching and support to the project team(s) and assure that those targets are achieved
  • Closely work with the post market teams to bring back the learnings from the fielded products
  • Work with the R&D team to implement design changes to fix issues
  • Define and manage the holistic patient and user safety, quality and reliability strategy
  • Oversee execution and quality of results, driving to sufficient confidence in the product/service prior to release to market
  • Ensure that appropriate Quality plans are made that include all stages of the product’s lifecycle
  • Validate key design inputs like usability, reliability, performance, safety, quality
  • Provide effective oversight on the execution of the Quality Plan and risk management activities
  • Lead quality related problem solving
  • Ensure the post-market data on the product’s performance is effectively used to make required design/process improvements
  • Act as a go-to subject matter expert for project team(s) and business functions

Requirements

  • Bachelor’s engineering degree with 12-14 years of experience / Master’s degree with 12+ years of experience; preferably in Quality or Reliability Engineering role in the medical or aerospace industry.
  • Additional R&D background and mindset with knowledge of product and software development processes would be desirable.
  • Preferably, you have a DfSS Green Belt certification and are willing to further develop towards Black Belt certification.
  • Experience in applying problem solving/root cause finding methodologies
  • Understanding of global medical device regulations, requirements, and standards, such as 21CFR820, ISO13485, EU MDR, IEC60601, IEC62366 and ISO14971 would be a plus.
  • Ability to define detailed Quality and Reliability plans for new medical product developments to ensure those are Safe, Effective and Reliable.
  • Ability to lead Risk Management and FMEA activities for new products and assurance that control measures are translated into appropriate (critical) requirements.
  • Strong exposure to application of Design Controls; ability to do thorough Design Reviews during new product development to ensure robust designs that further improve patient safety and product quality.
  • Ability to partner with Verification & Validation teams to assure thorough Verification, Validation and Useability testing.
  • Analyze development and field data for trends of Product Safety, Quality and Reliability performances and areas for further improvements of Product design and related development processes.
  • Strong experience with Systems Engineering methodologies / tools.
  • Experience with adequate and accurate review of DHF and DMR documents.
  • Experience with working in multidisciplinary teams in a high-tech R&D environment.
  • Effective interpersonal, written and oral communication skills expected.
  • Ability and willingness to work at least 3 days in office.
Benefits
  • A market conform salary
  • 25 Days of leave and the possibility to purchase up to 20 extra days off annually
  • A variable bonus based on both Philips results and personal performance
  • Extensive set of tools to drive your career, such as a personal development budget, free training and coaching
  • Solid company pension scheme and attractive collective health insurance package
  • Opportunity to buy Philips shares and products with discount
  • Healthy work-life balance
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Quality EngineeringReliability EngineeringDesign for Six Sigma (DfSS)Risk ManagementFailure Mode and Effects Analysis (FMEA)Design ControlsVerification and ValidationUsability TestingData AnalysisSystems Engineering
Soft Skills
CoachingProblem SolvingInterpersonal CommunicationWritten CommunicationOral CommunicationLeadershipCollaborationOrganizational SkillsCritical ThinkingAdaptability
Certifications
DfSS Green BeltDfSS Black Belt