Lead Development Engineer

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Marlborough, MA
3-5 Years Experience
Biotech
The Role

Be part of something altogether life-changing!

Working at Cytiva 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.

Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics.

The Development Engineer will be responsible for all aspects of product development, from concept design to a product’s commercial release. This responsibility includes line extensions of existing products and new product introductions (NPI). Activities may include concept design, procurement, inspection, and testing of materials, assembly of prototypes, creating specifications and drawings, conducting verification and validation from protocols through testing and reports, and adhering to design control standards and company processes.

This position is part of the Upstream and Fluid Management Research and Development team located in Marlborough, MA, and will be on-site. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.

What you will do:

  • Engage in all phases of product development, including concept, architecture, documentation, design, prototype, test, equipment operation, supplier interfaces, manufacturing introduction and service support.
  • Take responsibility for user requirements and product specifications, from product inception through commercial launch, including verification and validation to ensure the requirements and specifications were met (Design inputs, outputs, V&V).
  • Contribute to and lead design reviews to reduce risk, conduct trade-off analysis with program metrics (e.g. cost, schedule), and ensure continued alignment with business.
  • Conceptualize, prototype, model, and design parts and assemblies in CAD, create and modify drawings; generate engineering specifications, protocols, reports, and other documents associated with the development process.
  • Maintain compliance with design controls, new product development stage gate process, and site quality and regulatory system.

Who you are:

  • Bachelor’s degree in engineering with a minimum of 3 years of relevant product development, industry experience.
  • Experience working within an ISO 9001/13485 and/or cGMP environment.
  • Knowledge in statistical analysis, DOE, impact assessment, root cause analysis, and risk management/FMEA.
  • Experience using CAD and PDM systems such as SolidWorks, Inventor/Vault, and/or Creo/Windchill.
  • Effective written and verbal communication skills, with the ability to work collaboratively across all levels within a global, multidisciplinary team.

It would be a plus if you also possess previous experience in:

  • Biotechnology or medical device/life science field.
  • Bioprocess Engineering principals and methodology.
  • Computer-Aided Engineering analysis tools; FEA, CFD, MoldFlow.

At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

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.

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 protected] to request accommodation.

The Company
Marlborough, MA
8,399 Employees
On-site Workplace

What We Do

Cytiva, now with the life sciences business from Pall Corporation, is a global life sciences leader dedicated to helping customers discover and commercialize the next generation of therapeutics. Together, we bring dedicated technical expertise and a broad portfolio of tools and technologies that enable the development, manufacture, and delivery of transformative medicines to patients.

Visit cytiva.com to learn more.

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