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Description:

ACTUAL TITLE: Project Engineer Contractor, Hardware Product Care
ACTUAL ADDRESS: 800 Boston Turnpike
Shrewsbury, MA 01545
max billBR
max mark 1.48

This is a potential temp to perm position for the right candidate. Please ask your candidate(s) if they are legally authorized to work for any employer in the US without sponsorship and ensure the question is answered/confirmed in the comments when you submit the candidate(s). Thank you!



Role Summary

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.
Cytiva is looking for a Project Engineer to support the Hardware Product Care team with sustaining engineering activities of our Cytiva bioprocessing hardware product lines; bioreactors, mixers and hardware accessories.
The Project Engineer contractor position is located in Cytiva s new state-of-the-art hardware manufacturing facility in Shrewsbury, MA. The primary focus of this position is to support product testing and sustaining engineering activities for Upstream processing hardware equipment and accessories. 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 teams to resolve customer complaint investigations, drive root cause analysis to implement design, process and supplier quality related solutions.
Support the design, testing and release of Upstream Bioprocessing hardware products, components, assemblies, packaging, tooling and fixtures. Analyse and validate designs per user requirements to meet performance, cost, compliance and manufacturability targets.
Create and maintain DHF; detail drawings, schematics, 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.
Analyze and resolve quality issues, initiating sample build and lab testing, evaluating test samples, introduction and follow up of design changes in manufacturing.
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 Investigations.
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 (Requirements):

Bachelor s degree in either Electrical Engineering, Electronic or Instrumentation and controls Engineering.
Minimum 2 years of relevant experience in either Life Sciences, Bioprocessing, Pharmaceutical, Biotechnology, medical device development or a related field.
Experience in supporting projects/activities to meet customer requirements.
Familiar with industrial panel design, electro-mechanical components and assemblies such as; motors, pumps, motion controls, temperature controls and sensors.
Experience in Risk Management methodologies, Root Cause Analysis and CAPA activities.
Experience in selection and Design of PLC, Motor drives, Power supplies, I/O devices, Sensors, I/O Panels, and proven expertise in integrating these devices to the system.
Expertise in creation/modification of electrical schematics for wiring sensors, transmitters, devices, etc. in I/O cabinets.
Experience with 2D electrical computer aided design like AutoCAD Electrical/3D tools like E-Plan.
Experience in design of I/O cabinets for Automation panel, Components selection, layout design of cable/wire routings for I/O cabinets etc.
Hands on experience in design calculations-Power, Thermal etc. Critical components selection and evaluation for system level design.
Demonstrated ability to design industrial automation hardware systems to meet regulatory standards (UL, IEC, NFPA, CE Marking, LVD)
Experience in working with Engineering Change Orders (ECO) & Engineering Change Requests (ECR). Full knowledge of PLM or Equivalent. Working knowledge in design verification and testing, defect handling and ALM systems.
Experience on design documentation to comply with ISO and QMS systems.
Ability to work closely with remote team.
Understanding of materials, properties, manufacturing 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.
Experience working with and managing outside vendors (machine/mold shops, OEM s, metrology houses, testing facilities, etc.)
Strong communication and influencing skills and ability to gain buy-in for initiatives.







Desired

Master s degree in either; Electrical Engineering, Electronic or Instrumentation and controls Engineering.
Hands-on experience with Bioprocessing equipment and application methods.
Outstanding communication and writing skills for working with global manufacturing, marketing, and development teams.
Six Sigma Certification (Green Belt, Black Belt) or knowledge of DFSS.
Experience working in an Agile work environment.


About Us

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, Instagram channel and LinkedIn page!
Cytiva is a 3.3 billion USD 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.