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Danaher Corporation Lead Plastics Engineer in Marlborough, Massachusetts

Help us improve access to life-changing therapies that can transform human healthWe are Cytiva, a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. Formerly part of GE Healthcare, we have a rich heritage tracing back hundreds of years, and a fresh beginning since 2020.Our customers undertake life-saving activities. These range from fundamental biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies. Our job is to supply the tools and services - the pots, pans, soups and sauces - they need to work better, faster and safer, leading to better patient outcomes.What you'll doAs the Lead Plastics Engineer you will be responsible for design, prototype, develop and document new product offerings, single-use bioprocessing consumable products such as in the Xcellerex, WAVE, and ReadyToProcess product lines. Engage in all phases of product development, including concept, documentation, design, prototype, test, supplier interfaces, and manufacturing introduction.

  • Create 3D CAD part and assembly models, and detailed drawings complete with calculated dimensions and geometric (GD&T) tolerances

  • Procure materials, fabricate functional sub-systems for proof-of-concept evaluations, and confirm feasibility of design

  • Establish performance and functional specifications and requirements, identify critical to quality (CTQ) characteristics with cross-functional department input and VOC information, and ensure all are verifiable

  • Adhere to design control requirements including the creation of CAD models, assemblies, drawings, detailed specifications, design verification and validation plans, protocols and reports

  • Identify, collaborate and manage outside suppliers on material selection, tool design, manufacturing technologies and specifications for components, subassemblies, and/or finished assemblies

  • Experience with injection molding, extrusion, and thermoforming process and how part design, material selection, and tool design impact ability to produce high quality, repeatable parts

  • Ensuring compliance with Design History File (DHF) and other QMS requirements

  • Self-starter, creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues

  • Maintain and develop competence required for the job

  • Strong written and verbal communication skills

  • Generate and document intellectual property (IP)

  • Performs complex calculations, analyses, and testing to verify assumptions

Who you are

  • Bachelors degree in Mechanical, Plastics, or similar engineering or related field

  • 4 years relevant work experience

  • Experience with plastics and relevant material characteristics, particularly as used in disposable medical devices, life science, or biomedical products

  • Working knowledge of plastic part and assembly manufacturing

  • Familiar with SolidWorks, CREO, CAE analysis tools; FEA, CFD and MoldFlow

  • Experience in New Product Development, Cost Reduction, or part quality improvement

  • Experience with plastic part bonding, heat staking, snap fits, welding, etc

  • Understanding of relevant regulatory and QA guidelines governing single-use plastic components such as Biocompatibility requirements per USP Class VI and USP 87 Cytotoxicity

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

  • Prepare engineering change requests, engineering change notices, bills of material, engineering specifications, and customer submittals

  • Experience with stage gate development process

  • Experience working in ISO 13485 environment

  • Design for Six Sigma or Green Belt/Black Belt Certification

  • Demonstrated analytic approach to problem solving

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

Who we areWhatever your role, we bring purpose and challenge into our everyday work. If you are driven to make the world a better place thanks to science and medicine, you’ll feel right at home here. If you’re flexible, curious and relentless, you’ll belong. If you are excited about a global culture, this can be the place to further your career.Want to know more? Take a look at our Instagram, Twitter and LinkedIn pages!Cytiva is a 3.5 billion USD global life sciences leader with over 7000 associates across 40 countries who are dedicated to our mission to help us improve access to life-changing therapies that transform human health. As a trusted partner to customers that range in scale and scope, Cytiva brings efficiencies to research and manufacturing workflows, ensuring the development, manufacture and delivery of transformative medicines to patients.As part of the Danaher family of companies, our work at Cytiva is supported by a global science and technology innovator. In addition to Danaher’s unrivaled leadership training and professional development programs, our relationship also provides expanded career opportunities across industries and brands. Together, we are united by a shared purpose: Helping Realize Life’s Potential.

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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