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Danaher Corporation Senior Mechanical 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

  • Engage in all phases of new product development and change management for legacy products, including concept, architecture, documentation, design, prototype, test, supplier interfaces, manufacturing introduction and service support.

  • Elaborate with project team to develop product specifications and requirements to drive the product development process. Work from product specifications and requirements to develop component and assembly geometry, identify & specify materials, and establish acceptable performance standards. Perform modelling, complex calculations, analyses, and testing to verify assumptions.

  • Prepare engineering change requests (ECO/ECR), engineering change notices, bills of material, engineering specifications, design FMEA and customer submittals. Draft purchase specifications and quality control specifications. Revise and alter detailed and layout drawings to conform to engineering changes.

  • Direct the construction and testing of prototype disposables and pilot products, and conduct analysis of the test results performed through components verification activities.

  • Prepare using 2D and 3D CAD software mechanical drawings, assembly models.

  • Follow up of strategic suppliers providing plastic components such as injection molding, extrusions 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.

  • 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).

  • Minimum 8 year-experience in designing, developing and manufacturing plastic disposable kit products for regulated industry (medical device, class II and/or class III).

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

  • Proficiency in using SolidWorks modeling 3D CAD design software and FEA experience with ANSYS or equivalent applications. PDM experience is a plus.

  • Strong organizational and communication skills.

  • Experience in performing product verifications activities (protocol, test execution, report).

  • Experience in manufacturing processes development associated with a medical device or biological application is a strong asset (e.g. rapid prototyping technologies, injection molding, compression molding, tube extrusion, thermoforming, heat staking, ultrasonic welding, laser welding, snap-fitting, UV gluing, solvent bonding).

  • Knowledge of plastic biocompatibility, leachable & extractable and sterilization techniques is a plus.

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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