Danaher Corporation Lead Project Engineer, Investigations in Marlborough, Massachusetts
Help us improve access to life-changing therapies that can transform human health.
We 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.We are looking for a Lead Project Engineer to work with our expert Life Cycle Engineering team in Westborough, MA. The primary focus of this position is to lead sustaining engineering activities for single-use fluid pathway assemblies used in Upstream processing of biologics based on direct customer input. This position requires the application of design, root cause analysis investigation, product testing, data analysis and report writing to resolve and improve product design, process and quality issues all while working in a cross-functional team environment.What you’ll do
Interface directly with customers, suppliers and internal groups to resolve customer complaint investigations, drive root cause analysis and to implement design, process and supplier quality related solutions.
Lead customer complaint investigations and resolve customer issues.
Lead the design, testing and release single-use consumable products; components, assemblies, packaging, tooling and fixtures. Analyse and validate custom designs per user requirements to meet performance, cost, compliance and manufacturability targets.
Lead product design to meet their intended use. Ensure performance of engineering analyses (support and review FEA, CFD analyses) to lead design decisions.
Create and maintain DHF; detail drawings, specifications, assembly drawings and associated Bill-of-Materials, manufacturing documents, including initial assembly instructions, inspection criteria and packaging instructions.
Verify product performance against design inputs. Write verification protocols, perform testing, analyze and interpret test data, write and present verification reports.
Create manufacturing documents, including initial assembly instructions, inspection specifications, component specifications, and packaging instructions.
Release products through the ECR/ECO process.
Lead CAPA activities and complete Customer Complaint records in the TrackWise system.
Coordinate project priorities with team and Product Managers.
Self-manage tasks. Identify design requirements, perform risk assessments, identify required resources, estimate time and budget, and interface with peers, managers, suppliers and customers.
Maintain a safe work area.
Who you are
Bachelor's degree in either; BioEngineering, Mechanical Engineering, Chemical Engineering or Plastics Engineering.
Minimum of 3 years relevant experience in Bioprocessing, Pharma, or related Biotechnology field of work.
Experience in CAD systems; SolidWorks, Pro/ENGINEER or CREO using PDM/PLM systems.
Strong experience in plastic part design and GD&T per ASME Y14.5 standards.
Working knowledge of plastic material characteristics, particularly as used in disposable medical devices, or life science or biomedical products.
Knowledge of biocompatible material selection for sterile single-use applications in bioprocessing and/or medical device applications.
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, Power Point, Project and Visio.
Hands-on experience designing, prototyping and testing of components and assemblies.
Excellent communication and influencing skills and ability to gain buy-in for initiatives.
Master’s degree in either; BioEngineering, Mechanical Engineering, Chemical Engineering or Plastics Engineering.
Proficient with MS Project to create Project Plans, Work Breakdown Structures (WBS) and Gantt chart schedules.
Experience in CAE analysis tools; FEA, CFD and MoldFlow.
Outstanding communication and writing skills for working with global manufacturing, marketing, and development teams.
Experience in leading projects/activities to meet customer requirements.
Familiarity 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 with Scrum teams.
Application of Risk Management methodologies to aid in meeting commitments
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? Experience life at Cytiva on our Careers website, Instagram channel and LinkedIn page!Cytiva is a global life sciences leader with nearly 7000 associates across 40 countries who are dedicated to our mission to advance and accelerate therapeutics. 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.Cytiva is part of the Danaher family of companies, a global science and technology innovator committed to helping customers solve complex challenges and improving quality of life around the world.
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 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 require all US and Puerto Rico employees to be vaccinated against COVID–19 as a condition of employment, subject to reasonable accommodation as required by law.
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 firstname.lastname@example.org to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.