Danaher Corporation R&D Technical Lead in Hopkinton, 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. Your health and wellbeing are important to us and together we will not compromise on safety in the workplace or the environment.
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
Overall design, development and design transfer responsibility of the disposable kits during execution of new product or legacy product engineering projects. Make sure that a complete solution is designed where all included parts, sub-assemblies, sterile finished good or products are contributing to meet the customer expectations and product specifications (URS, SRS).
Ensure that applicable customer URS requirements are tracked and fulfilled.
Regulatory fulfilment of delivered products.
Represent Cytiva in technical discussions with customers and notified bodies.
Coordinate the detailed design and solve any issues during the design phase.
Coordinate and approve the product design verification and validation activities during development phase.
Coordinate and approve the design transfer activities for NPI performed through CMOs and/or done internally. Support design transfer activities when it relates to legacy product engineering activities.
Chair technical design reviews and meetings, be able to identify and solve technical risks and problems.
Support project manager in the planning of product development activities.
Support quality audits by providing engineering and technical support, when requested.
Follow up of strategic suppliers providing plastic components such as injection molding, extrusion components or bags and cryo-bags.
Work in a multidisciplinary Research and Development team, in close interaction with the production, Supply Chain, Quality and Sales & Marketing departments, as well as end-users and suppliers.
Who you are
Master’s degree or equivalent in related scientific or engineering fields (mechanics, plastics, material sciences, biomedical engineering or micro-mechanics).
10+ year-experience in designing, developing and manufacturing plastic disposable kit products or equivalent for regulated industry (medical device, class II and/or class III), including the documentation associated to URS, SRS, design FMEA and V&V.
Very well-founded knowledge and practical experience of relevant regulations (ISO13485, FDA 21 CFR Part 820), specifically for the US and European market product submission.
Experience in manufacturing processes development (e.g. rapid prototyping technologies, injection molding, compression molding, tube extrusion, thermoforming, heat staking, heat sealing, ultrasonic welding, laser welding, snap-fitting, UV gluing, solvent bonding) associated with a medical device or biological application, including the whole documentation related to FAT, SAT, IQ, DOE & characterization, OQ, PQ, process FMEA, Gage R&R, Cpk process capability, SPC.
Strong organizational and communication skills in multisite, multidisciplinary, multicultural matrix organization.
Customer focus and results driven, deliver on time and constantly meet customer expectations.
Good integrity. Able to speak his/her mind openly and get the message across.
Quality First culture, design product for reliability and manufacturability. Six Sigma Certification (Green Belt, Black Belt) or knowledge of DFSS.
Desire and willingness to mentor and coach team members and colleagues.
Demonstrated collaboration, negotiation & conflict resolution skills.
Ability to multi-task & handle tasks with competing priorities effectively.
Strong analytical, process skills and project management skills. PMI certification is an asset.
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 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 email@example.com to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.