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Danaher Corporation Engineer, Custom Consumables 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

  • Support the design, testing and release of single-use consumable products; components, assemblies, packaging, tooling and fixtures. Analyze and validate custom designs per user requirements to meet performance, cost, compliance and manufacturability targets.

  • Author Project documentation including testing protocols/reports, product risk analysis, design documentation, and task Gantts.

  • Supports Project documentation including project plan, requirements, and program risk analysis.

  • Participates as part of cross functional team and receives direction from project lead to achieve project deliverables.

  • Maintains task Gantts and communicates task status to Project Lead.

  • Responsible for design of custom single-use products; components, assemblies, packaging, and fixtures.

  • Analyze and validate designs per user requirements to meet performance, cost, compliance and manufacturability targets.

  • Leverages historical test data and applies engineering judgement to rationalize verification testing where appropriate.

  • Adheres to predefined process for release of new products.

  • Produces engineering analyses and test results with high confidence.

  • Builds prototypes and verification test samples.

  • Manage activity at external test facilities to develop prototype & test samples, and to complete verification activities.

  • Release documentation through ECR/ECO change control process.

  • Facilitates and supports transfer to manufacturing.

  • Ensures products meet regulatory requirements.

  • Self-manage tasks.

  • Provides retrospective insight to support performance and efficiency improvements to processes and procedures.

  • Maintain a safe work area.

Who you are

  • Bachelor’s degree in either Mechanical Engineering, Plastics Engineering, or BioEngineering.

  • Minimum 2 years of relevant experience in Mechanical engineering, Biological Sciences, Biotechnology, medical device development or a related field.

  • Minimum 2 years of experience in product development

  • Experience in supporting projects/activities to meet customer requirements.

  • Proficient with Gantt chart schedules.

  • Application of Risk Management methodologies.

  • Ability to work closely with remote team.

  • Experience in CAD solid modeling tools; preferably SolidWorks and/or CREO.

  • Experience in plastic part design and GD&T per ASME Y14.5 standards.

  • Working knowledge of plastic material characteristics and manufacturing processes, particularly as used in disposable medical devices, or life science or biomedical products.

  • Knowledge of bio-compatible material selection for sterile single-use application in bio-processing and/or medical device applications.

  • Knowledge of sterilization methods for pharmaceutical equipment and/or medical devices.

  • Understanding of materials, properties, Mfg. processes, and product assembly.

  • Awareness of GMP and governmental regulations related to drug manufacturing sufficient to appreciate the need for documentation accuracy.

  • Ability to read and interpret professional journals and technical procedures, write test protocols and reports; communicate test analysis and results.

  • Proficient with Microsoft tools; Word, Excel, and Power Point.

  • Hands-on experience designing, prototyping and testing of components and assemblies.

  • Experience working with and managing outside vendors (machine/mold shops, OEM’s, metrology houses, testing facilities, etc.)

  • Excellent communication and influencing skills and ability to gain buy-in for initiatives.

    Desired

  • Master’s degree in either; Mechanical Engineering, Plastics Engineering or BioEngineering.

  • Experience in Intellectual Property

  • Hands-on experience with BioProcessing equipment and application methods.

  • Proficient in CAD solid modeling tools; preferably SolidWorks and/or CREO.

  • Experience in CAE analysis tools; FEA, CFD and MoldFlow.

  • Outstanding communication and writing skills for working with global manufacturing, marketing, and development teams.

  • Proficient with relevant regulatory and Q/A guidelines governing single-use plastic components such as Biocompatibility requirements per USP Class VI and ISO-10993.

  • Six Sigma Certification (Green Belt, Black Belt) or knowledge of DFSS.

  • Experience working in an Agile work environment.

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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