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Danaher Corporation R&D - Senior Design Transfer Engineer (m/f/d) in Eysins, Switzerland

Be part of something altogether life-changing

Working at Cytiva in the Life Sciences industry means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.

At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40 countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term.

Cytiva is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

We are looking for a R&D Senior Design Transfer Engineer to work with our expert Cell and Gene Therapy Disposables R&D team of more than 20 employees across the world. Do you have a passion for developing products which will influence the future of medical technologies? Then we would love to hear from you.

What you’ll do

  • Establish equipment requirements by working closely with product design team, suppliers and the cross-functional project team. Align the equipment specifications to reliability and quality requirements within the framework of new products development or management of legacy products.

  • Lead the team with hands-on work related to process development by performing process characterization through DOE to define key parameters and process window to meet the quality goals.

  • Apply Analytical and quantitative problem-solving using methods including but not limited to Root Cause Analysis and Design of Experiments.

  • Ensure Design Output meets the goals set by User Requirement Specifications and System Requirement Specifications.

  • Define Manufacturing Process Flow, Master Validation Plan for the overall Manufacturing Process as well as Qualification Strategy for individual equipment.

  • Own the DMR for NPI and lead preparation of protocols, test execution and test report for qualification documents including Factory Acceptance Test (FAT), Supplier Acceptance Test (SAT), Installation Qualification (IQ), Process Characterization (DOE), Operational Qualification (OQ), and Performance Qualification (PQ), Process FMEA, Gage R&R, Process Capability (Cpk), Statistical Process Control (SPC), Purchase specifications and Quality Control Specifications.

  • Propose and lead projects that will improve manufacturing performance, reduce costs, improve yields, or reduce cycle time.

  • Own the Cost of Good of products for any NPI or change implemented on legacy products from components to sterile finish good.

  • Publish standard methodologies around Process Development; coach and mentor team members on Lessons Learned.

  • Support Manufacturing Engineering Team and Market Support Team for complex issue solving for legacy products (e.g. production issues, customer complaints, customer requests).

  • Work in a multidisciplinary Research and Development team, in close interaction with the Production, Supply Chain, Sourcing and Quality departments, as well as suppliers.

  • Support project manager in the planning of mechanical development activities.

  • Support quality audits to provide engineering and technical support, when requested.

Who you are

  • Master’s degree or equivalent in related scientific or engineering fields (mechanics, micro-mechanics, engineering).

  • 10+ year-experience in designing, developing, transferring and maintaining manufacturing technologies and processes associated with regulated industry (medical device, class II and/or class III).

  • Founded knowledge and practical experience of relevant regulations (ISO13485, FDA 21 CFR Part 820), specifically for the US and European market product submission.

  • Strong organizational and communication skills (min C1 level in French and English).

  • 5+ year-experience in performing qualification and validation of manufacturing process (IQ, DOE, OQ, PQ, Process FMEA).

  • Familiar with the following manufacturing processes in the medical device industry: machining, injection molding, compression molding, tube extrusion, thermoforming, heat staking, heat sealing, ultrasonic welding, laser welding, snap-fitting, UV gluing, solvent bonding, automated assembling, labelling, packaging. Experience with sterilization processes is a plus (Gamma, EtO).

  • Self-starter, hands-on, creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues

  • Green Belt or Black Belt certification is a strong asset.

Who we are

When you join us, you’ll also be joining Danaher’s global organization, where 68,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.

Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.

If you’ve ever wondered what’s within you, there’s no better time to find out.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .

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