Design Quality Engineering Expert

vor 1 Woche

Baar, Schweiz Medela LLC Vollzeit

You provide technical quality engineering support to our new product development teams focusing on design related projects and deliverables required by the Design Control Process (DCP) to ensure quality, safety, usability and performance within product design. We are looking for a person with strong understanding of systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

Join Medela and help us turn science into care

This is what you can move
- Provide quality support to project teams in product development and in support to product care changes; ensure that all product development projects meet applicable regulatory (local and international), customer and stakeholder requirements
- Review, assess and approve product design milestones and deliverables throughout product development cycle to ensure compliance to customer and regulatory requirements
- Determine project metric trough the VOC tools
- Ensure that corrective measures meet acceptable quality and reliability standards
- Develop, coordinate and support technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE).
- Recommend/review design or test methods and statistical data analysis, including sample size determination, for achieving required levels of product quality/reliability
- Support new test development and appropriate test method validation (TMV)
- Conducts/coordinates risk management activities (Risk Management Plan/Report, Risk Analysis and Control, Benefit Risk Analysis, etc.) including review failure mode effects analysis (FMEAs)

What you bring along
- Degree in Electrical, Mechanical or Industrial Engineering or equivalent; Specific training in quality assurance / risk management required (e.g., ISO13485, ISO14971) and / or regulatory affairs
- At least seven years’ work experience in a Product Development/Design Assurance function in regulated environment (e.g. automotive, aviation)
- English spoken and written fluently
- In depth know-how and experience of Six Sigma methods such as VOC, CTQ, QFD, SIPOC, DMAIC, DoE, Kaizen, etc.
- In deep knowledge of Risk Assessment methodologies (e.g. PHA, HAZOP, Bowtie methodology, What-if hazard analysis, FMEA, FTA, etc.)
- Statistical techniques, design of experiment (DOE), analysis and sampling methods

What we offer you
- Medela Family: A culture characterized by inclusivity and respect that values and supports every member of our team. Together, we pursue one goal: improving the lives of mothers, babies and patients by translating science into care.
- Flexibility: If your role allows for it, you can work in a hybrid model with up to 3 days per week working from home.
- Growth Opportunities: a range of learning initiatives, both on and off the job.
- Competitive package: Benefits align with international benchmarks, including extended maternity/paternity leave, insurance, and additional vacation or bridge days.
- Balance: A variety of activities designed to promote health and well-being.

The hiring process of this position is supported by the responsible Talent Acquisition Manager Julia Winkler case of specific questions please contact us on +41 41 562 1077.

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