Danaher Corporation Senior Project Engineer, Hardware Product Care in Shrewsbury, 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.
Senior Project Engineer, Hardware Product Care
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
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 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) .
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