The R&D Process Development Engineer will be responsible for leading process development, technology transfer, and supporting production scale-up for existing products and new product introductions (NPI) for our R&D team at GE Life Sciences in Marlborough and Westborough, MA.
Essential Responsibilities:
Current processes include our hollow-fiber filter manufacturing (polymer extrusion and membrane fabrication), and our assembly lines for single-use fluid pathway consumable products. Our products are used with bioreactors and related bioprocess manufacturing equipment in the pharmaceutical industry and are essential to produce lifesaving medicines and treatments.
- Work hands-on to install, modify, and de-bug new and existing manufacturing equipment, applying analytical knowledge and mechanical aptitude.
- Characterize the impact of equipment process variables on design outputs.
- Lead the selection, capital acquisition, and acceptance testing of equipment based on analysis of specifications, risks, reliability and quality/regulatory requirements.
- Conduct and support process qualifications.
- Generate, review and update the technical content of drawings, engineering specifications, equipment specifications, protocols, reports, and other documents associated with the engineering process, and lead/participate in formal engineering design reviews.
- Complete PFMEA, Control Plan, and support SOP generation associated with product transfers and launches.
- Generate, execute and analyze DOE, characterization and measurement system analysis (MSA) studies for new products and new processes.
- Release products through the ECR/ECO process.
- Aid in design of large and small equipment to meet their intended use. Ensure performance of engineering analyses (e.g., free-body diagrams, stress analyses) to aid in making design decisions.
- Participate in cross-functional teams, working primarily in production alongside Manufacturing engineers at the Westborough site, in a highly matrixed team environment to advance programs.
- Ensure adherence to GMP and EHS safety procedures.
Qualifications/Requirements:
- Bachelor’s degree in Engineering with 5+ years of relevant process/operations experience in mechanical engineering, Biotechnology or a related medical device/life science field.
- Strong mechanical aptitude, previous experience designing and executing equipment qualifications (IQ/OQ/PQ) and DOEs, knowledge of automation and PLCs, thorough understanding of electrical/mechanical, fluid delivery/pumps, and pneumatic systems.
- Excellent verbal and written communication skills to technically and professionally describe test scenarios, deviations, non-compliances and risks.
- GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
Desired Characteristics:
- Experience in Medical Device (ISO13485), Pharmaceutical GMP environments.
- Previous experience with various forms of polymer welding; traditional heat sealing (continuous & impulse) friction welding, ultrasonic and inductive would be a plus.
- Experience with equipment used in the manufacture of hollow fiber, fiber spinning, melt spinning, and wet spinning.
- Design for Six Sigma or Green Belt/Black Belt Certification.
There is no other life sciences company quite like GE Healthcare Life Sciences. A $5 billion business with more than 11,000 individuals in over 100 countries, we are at work enabling a new era in medicine. For more than 60 years, GE Healthcare Life Sciences has globally supported the development and use of new therapies, helping accelerate the journey from biological understanding to clinical therapy. GE Healthcare Life Sciences works with cutting-edge technology enabling and advancing the discovery, diagnosis and medical treatments of the present and the future. We are accelerating biology to cell therapy in ways no other company can.
GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world.GE works on things that matter - great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients.
