Danaher Corporation Senior Project Engineer, Hardware Product Care in Shrewsbury, Massachusetts
Senior Project Engineer, Hardware Product Care
Help us improve access to life-changing therapies that can transform human health
Cytiva is a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. Formerly part of GE Healthcare Life Sciences, we have a rich heritage tracing back hundreds of years, and a fresh beginning since 2020. Our customers undertake life-saving activities ranging 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 they need to work better, faster and safer, leading to better patient outcomes.
Whether you’re a biochemist, a finance guru or manufacturing professional, 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 is your place to further your career.
We are looking for a Senior Project Engineer in our Hardware Product Care Life Cycle Engineering team located at our new facility in Shrewsbury, MA. The primary focus of this position is to lead sustaining engineering activities for Bioprocessing hardware and single-use fluid pathway assemblies for 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
As a Senior Project Engineer you will be responsible for system design and sustaining engineering activities for bioprocessing hardware product lines such as Bioreactors, Mixers, and accessories.
Design tasks include system level architecture, control panel design and electromechanical systems, EMI/EMC design and mitigation, electronic component selection.
Involve in all phases of new product development, including concept, architecture, documentation, design, prototype, test, supplier interfaces, manufacturing introduction and service support
Lead the design, testing and release of bioprocessing hardware products; components, assemblies, tooling and fixtures. Analyze 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 to lead design decisions.
Create and maintain DHF; schematics, specifications, assembly drawings and associated Bill-of-Materials, manufacturing documents, including initial assembly instructions and inspection criteria.
Analyze and resolve quality issues, initiating sample build and lab testing, evaluating test samples, introduction and follow up of design changes in manufacturing.
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.
Verify product performance against design inputs. Write verification protocols, perform testing, analyze and interpret test data, write and present verification reports.
Create Design of Experiments, test strategies and design verification & validation strategies for bioprocessing equipment, providing technical support and leadership with cross-functional teams.
Release products changes 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.
Maintain a safe work area.
Who you are
Bachelor's degree in either; Electrical Engineering, Mechanical Engineering or Industrial Engineering.
Minimum of 8 years experience with at least 4 years relevant experience in either Bioprocessing, Pharma, Medical Device, or related Biotechnology field of work.
Strong experience in industrial panel design with electromechanical components such as; PLC controllers, pumps, motors, sensors and temperature control systems.
Ability to be responsive to customer’s requests to lead customer complaint investigations, complete Root Cause Analysis and implement risk management methodologies.
Proficient in CAD tools such as SolidWorks, Pro/Engineer, CREO and Autodesk AutoCad or similar CAD tools.
Able to develop and implement Test Method Validations, test procedures and work instructions.
Experience in designing and supporting products to comply with international regulatory compliance including; RoHS, IPC, IEC. Working Knowledge of regulatory standards; UL/CE/IEC.
Proficient with Microsoft tools; Word, Excel, Power Point, Project and Visio.
Hands-on experience designing, prototyping and testing of components and assemblies.
Strong communication and influencing skills and ability to gain consensus for initiatives.
Master’s degree in either; Bachelor's degree in either Electrical Engineering, Mechanical Engineering, or Industrial Engineering.
Project Management Professional (PMI/PMP) Certification.
Knowledge of bio-compatible material selection for sterile single-use application in bio-processing and/or medical device applications.
Familiar with Veeva or TrackWise CAPA systems.
Proficient with MS Project to create Project Plans, Work Breakdown Structures (WBS) and Gantt chart schedules.
Experience in CAE analysis tools such as; FEA and CFD.
Automation experience in PLC programming.
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 are
Whatever 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 (https://jobs.danaher.com/global/en/cytiva) , Instagram channel (https://www.instagram.com/cytiva/) and LinkedIn page (https://www.linkedin.com/company/cytiva/) !
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.
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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