As a Senior Design Quality Engineer, you will play a critical role in shaping the future of medical technology. You will ensure that our innovative medical products not only meet but exceed the highest standards of quality, safety, and reliability. This is more than a job; it’s a mission to improve and save lives.
Set the quality and reliability targets for our IGT Systems medical products, ensuring every new design is built for excellence.Use your deep expertise in quality and reliability engineering to guide and support project teams, acting as a trusted advisor and confident subject matter expert.Collaborate with post-market teams to analyze field data and implement design changes that continuously improve our products.
- Partner with cross-functional teams to define and manage the holistic safety, quality, and reliability strategy for new products.
- Develop and oversee quality plans that cover the entire product lifecycle, from initial concept to market release.
- Lead the validation of key design inputs like usability, reliability, and performance, ensuring we meet strict statistical confidence and reliability levels.
- Lead problem-solving initiatives and ensure that post-market data is effectively used to drive design and process improvements.
- Act as the go-to subject matter expert on all Design Control processes, ensuring every product design meets our stringent quality standards.
- Make substantial contributions to integrating requirements engineering and CTQ (Critical to Quality) activities into our medical device development process.
Functie-eisen
- Bachelor’s degree in engineering with 12+ years of experience, or a Master’s degree with 8+ years of experience, preferably in a Quality or Reliability Engineering role within the medical or aerospace industry.
- Proven experience in applying problem-solving and root cause analysis methodologies.
- Strong experience with Design Controls and conducting thorough Design Reviews to ensure robust product designs.
- Demonstrated ability to partner with Verification & Validation teams to ensure comprehensive testing.
- Experience with Systems Engineering methodologies and tools.
- Strong analytical skills with the ability to analyze development and field data to identify trends and areas for improvement.
- Effective interpersonal, written, and oral communication skills.
- Ability and willingness to work at least 3 days in the office.
- Additional R&D background and mindset with knowledge of product and software development processes.
- DfSS Green Belt certification (with a willingness to pursue Black Belt certification).
- Understanding of global medical device regulations such as 21CFR820, ISO13485, EU MDR, IEC60601, IEC62366, and ISO14971.
Competenties
- Ability to express ideas clearly, both in writing and when speaking, and to listen well to others.
- Skill of working effectively with others to achieve a shared goal.
- Ability to identify issues and find practical solutions.
- Capacity to handle change and adjust to new situations or challenges.
- Trait of being dependable, showing up on time, and completing tasks as promised.
Arbeidsvoorwaarden
Primary employment conditions:
- A good salary as per market standards.
- 13th month salary
- 8.33% holiday pay calculated over 12 monthly salaries.
- Pension Plus scheme (build-up from day 1)
- Just €750 to set up your home workplace
- 13th month (paid periodically on a pro-rata basis) or the possibility of a bonus (4 to 8% per quarter - average of 1 month's salary per year)
- 25 days of vacation per year based on 40 hours
- Travel expenses reimbursement
- Options for working from home with a home work allowance
- Yacht Academy with a training budget of up to €3,500 per year
- Referral bonuses up to €1,500
Bedrijfsinformatie
You will be part of the global Philips Patient Safety & Quality organization, reporting to the Design Quality team for our IGT-Systems Business. Our team is dedicated to exceeding both internal and external stakeholder expectations by relentlessly striving for product quality improvements.
Join us and help create a better, healthier world through your passion for quality.
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent.
contact
Sowmya Kandukuri
sowmya.kandukuri@yacht.nl
+918374294984
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