We are seeking a for a Engineering Project Manager to provide critical bioprocess knowledge to our Product Care Life Cycle Engineering team.
Our client is a leading manufacturer and distributor of diagnostic imaging agents and radiopharmaceuticals for imaging modalities that are used in medical imaging procedures
We at Ian Martin envision a world where everyone is connected in meaningful work and if you find great meaning in developing some of the most widely used products in the world, then we have the career path for you.
On a day to day basis your work will include:
The Lead Project Engineer position is located in the Westborough R&D Life Cycle Engineering group within the Biotechnology business area in GE Healthcare Life Sciences. The primary focus of this position is to provide technical guidance and expertise in the bioprocess area with applications and engineering knowledge of single-use bioreactor systems; cell bags and hollow fiber filtration. This position requires the application of design, investigation root cause analysis, product testing, data analysis and report writing to resolve customer complaints / product issues and implement existing product design improvements, all while working in a cross-functional team environment.
The successful candidate should have in-depth technical knowledge and sound business acumen as well as excellent communication skills to work across multiple internal teams and with customers.
- Function as an internal and external technical expert for upstream single-use bioprocessing equipment, products, processing and application methods.
- 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 the design, testing and release of single-use consumable products; components, assemblies, packaging, tooling and fixtures.
- Proficient in CAD solid modeling tools; preferably SolidWorks and/or CREO.
- Leading 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, and 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 track Customer Complaint Investigation records in 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.
- Bachelor’s degree in either; Mechanical Engineering, Chemical Engineering, Plastics Engineering or BioEngineering.
- 5 years relevant experience in biopharmaceutical processing, medical device or related Biotechnology field of work.
- 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 bio-compatible material selection for sterile single-use application in bio-processing and/or medical device applications.
- Strong understanding of materials, properties, Mfg. 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, 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.
Looking for Meaningful Work? We can help.
If you're a technical professional, you know that it can be difficult to find fulfilling work that advances your career. At the Ian Martin Group, we exist to connect professionals like you with meaningful work at industry-leading companies in your field. And we walk the walk, too: as a Certified B Corporation, we believe in using business as a force for good for people, our communities, and the environment.
We value diversity and inclusion and encourage all qualified people to apply. If we can make this easier through accommodation in the recruitment process, please contact us at firstname.lastname@example.org.
We encourage all qualified candidates to apply; however, only those selected for an interview will be contacted.