Danaher Corporation R&D Senior Design Transfer Engineer in Marlborough, Massachusetts
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.
What you’ll do!
Establish equipment requirements by working closely with product design team, suppliers and the multi-functional project team.
Align the equipment specifications to reliability and quality requirements within the framework of new products development or management of legacy products.
Apply Analytical and quantitative problem-solving using methods including but not limited to Root Cause Analysis and Design of Experiments.
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.
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.
Who you are!
Bachelor’s degree required. Master’s degree or equivalent in related scientific or engineering fields (mechanics, micro-mechanics, engineering) preferred.
5+ years’ experience in designing, developing, transferring and maintaining manufacturing technologies and processes associated with regulated industry (medical device, class II and/or class III).
5+ years’ experience in performing qualification and validation of manufacturing process (IQ, DOE, OQ, PQ, Process FMEA).
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 interpersonal skills.
Familiar with the following manufacturing processes: machining, injection molding, compression molding, tube extrusion, thermoforming, heat staking, heat sealing, ultrasonic welding, laser welding, snap-fitting, UV gluing, solvent bonding, automated assembling, labeling, packaging or other related experience.
Self-starter, hands-on, creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues.
We offer comprehensive benefits including Medical, Dental, Vision and a matching 401K!
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 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 mentorship from dedicated leaders, all with the support of powerful 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.
We help you realize your life’s potential with a competitive benefits package. At Danaher, we provide a suite of benefits to support your physical, financial, and emotional wellbeing. Speak with your recruiter or hiring manager to learn more about country-specific offerings.
Individuals who need a reasonable accommodation because of a disability for any part of the employment process should call 202-419-7762 or e-mail email@example.com to request accommodation.
If you’ve ever wondered what’s within you, there’s no better time to find out.
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 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 Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at firstname.lastname@example.org to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.
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