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Process Engineer (2 years+) (Medical Manufacturing)
Job description
Text:
TL;DR
Process Engineer (2 years+) (Medical Manufacturing): Developing, optimizing, validating, and transferring manufacturing processes for regulated medical technologies with an accent on statistical process control, equipment qualification, compliance, and production efficiency. Focus on process characterization, root cause analysis, scalable automation, risk management, and technology transfer to manufacturing operations.
Location: Humacao, Puerto Rico, United States of America; onsite
Company
develops healthcare technologies designed to alleviate pain, restore health, and extend life.
What you will do
- Provide technical and sustaining engineering support in a manufacturing area.
- Recommend and implement equipment and process modifications to improve quality, efficiency, manufacturing techniques, and production yields.
- Develop, optimize, characterize, and validate manufacturing processes, including equipment, materials, tooling, fixtures, and measurement systems.
- Lead feasibility studies, process and equipment selection, installation, assessment, and technology transfer to manufacturing operations.
- Collaborate with R&D, product design, Quality, Operations, Supply Chain, and suppliers to align processes with product requirements.
- Ensure processes comply with applicable regulations while supporting statistical analysis, cost reduction, and value engineering.
Requirements
- Bachelor’s degree in engineering and at least 2 years of relevant experience, or a master’s degree with 0 years of relevant experience.
- Lean Manufacturing and Six Sigma experience with Green Belt or Black Belt certification.
- Advanced statistical analysis skills, including DOE, SPC, MSA, and process capability studies.
- Experience with automation, digital manufacturing, equipment qualification and validation, including IQ/OQ/PQ.
- Knowledge of FMEA, Fault Tree Analysis, FDA QSR, ISO 13485, and GMP.
- Must have unrestricted U.S. work authorization at the time of hire and throughout employment; sponsorship is offered only for Principal-level roles and above.
Nice to have
- Experience with Minitab, JMP, Power BI, or Python for data analysis.
- Supplier process development and oversight experience.
- Experience with change management, ECO execution, NCMR and CAPA investigations, and technology transfer.
- Project management knowledge, including Agile or PMP fundamentals.
- Experience mentoring or technically coaching junior engineers.
Culture & Benefits
- Full-time employment at a global healthcare technology company.
- Competitive compensation and a flexible benefits package.
- Eligibility for the Incentive Plan short-term incentive.
- Reasonable accommodations are available for qualified individuals with disabilities.