1 день назад
Senior Manufacturing Engineer (Medtech)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Manufacturing Engineer (Medtech): Developing and optimizing manufacturing processes, production layouts, equipment implementations, and validation activities for medical technology production with an accent on process efficiency, quality, compliance, and scale-up. Focus on designing production systems, troubleshooting machinery, applying statistical process control, and implementing automation and continuous improvement initiatives.
Location: Humacao, Puerto Rico, United States of America; onsite role
Competitive salary and benefits package; eligible for the Incentive Plan short-term incentive.
Company
develops healthcare technologies designed to alleviate pain, restore health, and extend life.
What you will do
- Lead and support manufacturing process development, optimization, continuous improvement, and scale-up.
- Design manufacturing processes, production layouts, equipment arrangements, operating sequences, tools, and fixtures.
- Support equipment implementation, troubleshooting, inspection, testing, and corrective actions to improve product quality.
- Develop processes suitable for statistical process control and ensure manufacturing procedures comply with applicable regulations.
- Provide technical guidance on design concepts, specifications, equipment utilization, and manufacturing techniques.
- Partner with Operations, Quality, Supply Chain, and R&D on new product introductions and manufacturing excellence.
Requirements
- Bachelor’s degree in engineering and at least 4 years of relevant experience, or a master’s degree with at least 2 years of relevant experience, or a PhD with no required experience.
- Unrestricted U.S. work authorization is required at hiring and throughout employment.
- U.S. work authorization sponsorship is not available for this role; sponsorship is limited to Principal-level roles and above.
- Degrees earned outside the United States must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).
- Ability to work with manufacturing processes, equipment, production layouts, quality investigations, and regulatory compliance.
Nice to have
- Experience with CNC programming, cutting tools, inspection gauges, GD&T, stack-up analysis, and CAD software such as Creo, AutoCAD, or PartMaker.
- Knowledge of process validation, including DOE, IQ/OQ/PQ, Gage R&R, SPC, MSA, and capability studies.
- Experience with automation, robotics, PLC programming, digital manufacturing, laser processes, and product inspection systems.
- Knowledge of sterile packaging, sterilization, cleaning, anodizing, assembly processes, jigs, and fixtures.
- Experience with Lean Manufacturing, Six Sigma, FMEA, CAPA, FDA QSR, ISO 13485, GMP, data analytics, and cost reduction.
Culture & Benefits
- Purpose-driven work focused on healthcare technology and patient outcomes.
- Competitive compensation and a flexible benefits package.
- Short-term incentive eligibility through the Incentive Plan.
- Equal employment opportunity and reasonable accommodation for qualified individuals with disabilities.
- Full-time employment with access to resources intended to support employees across career and life stages.
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