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Sr Process Engineer (Medical Devices)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Sr Process Engineer (Medical Devices): Developing, optimizing, and validating manufacturing processes for regulated medical-device production with an accent on Lean Manufacturing, Six Sigma, statistical analysis, automation, and equipment qualification. Focus on leading process validation, solving quality and yield issues, transferring technology to manufacturing, and ensuring compliance with FDA QSR, ISO 13485, and GMP requirements.
Location: Humacao, Puerto Rico, United States of America; onsite manufacturing role
Company
develops healthcare technologies designed to alleviate pain, restore health, and extend life, serving patients across more than 150 countries.
What you will do
- Provide technical and sustaining engineering support in a regulated manufacturing area.
- Develop, optimize, and modify equipment and manufacturing processes to improve quality, yield, reliability, and production efficiency.
- Lead process characterization, statistical process control, measurement systems, equipment qualification, and validation activities.
- Evaluate materials, tooling, fixtures, equipment, process feasibility, and technology-transfer requirements for scale-up.
- Collaborate with R&D, Quality, Operations, Supply Chain, product design, and development teams.
- Ensure manufacturing processes and procedures comply with applicable regulations and quality standards.
Requirements
- Bachelor’s degree in engineering with at least 4 years of relevant experience, or a master’s degree with 2 years of relevant experience, or a PhD with no experience required.
- Lean Manufacturing and Six Sigma experience with Green Belt or Black Belt certification.
- Advanced statistical analysis experience, including DOE, SPC, MSA, and process capability studies.
- Experience with automation, digital manufacturing, equipment qualification and validation, risk management, technology transfer, and supplier process development.
- Knowledge of FDA QSR, ISO 13485, GMP, FMEA, Fault Tree Analysis, DFM/DFA, ECO execution, and nonconformance or CAPA investigations.
- Must possess unrestricted U.S. work authorization at the time of hire and throughout employment; sponsorship is offered only for Principal-level roles and above.
Culture & Benefits
- Full-time employment with competitive compensation and flexible benefits.
- Eligibility for the Incentive Plan short-term incentive.
- Work focused on medical technologies and patient impact.
- Reasonable accommodations are available for qualified individuals with disabilities.
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