3 дня назад
Sr Manufacturing Engineer
102 400 - 153 600$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Sr Manufacturing Engineer (Medical Devices): Supporting released spine products and new product launches through manufacturing operations, product transfers, process validation, and engineering change implementation with an accent on regulated medical-device manufacturing and cross-functional technical support. Focus on developing IQ/OQ/PQ activities, resolving production and supplier constraints, improving process capability, and maintaining compliance with quality and regulatory requirements.
Location: Onsite in Memphis, Tennessee, United States. The role requires unrestricted U.S. work authorization at the time of hire and throughout employment.
Salary: $102,400–$153,600 per year, plus eligibility for the Incentive Plan.
Company
develops healthcare technologies for neurological, spine, chronic pain, and other medical applications, serving patients across more than 150 countries.
What you will do
- Manage technical product and process transfers to manufacturing partners.
- Lead design and process changes through PLM systems and formal change-control processes.
- Provide engineering guidance for production issues, manufacturing equipment, inspection challenges, and product sustainment.
- Develop and execute process validation and qualification activities, including IQ, OQ, and PQ.
- Partner with cross-functional teams on MSA, process capability, continuous improvement, CAPA, and rework evaluations.
- Collaborate with Supply Chain and Operations to resolve manufacturing constraints, backorders, and supplier-related technical issues.
Requirements
- Bachelor’s degree in Engineering and 4+ years of manufacturing engineering experience, or a master’s degree with 2+ years, or a PhD with 0+ years of experience.
- Experience supporting manufacturing processes, production operations, process improvements, or engineering changes in a regulated environment.
- Knowledge of process validation, manufacturing process controls, SPC, MSA, GR&R, gauge applications, sampling, and data analysis.
- Experience with medical-device manufacturing processes such as machining, molding, grinding, forming, assembly, welding, finishing, cleaning, coatings, EDM, casting, forging, or polishing.
- Strong analytical, problem-solving, communication, project management, and cross-functional collaboration skills.
- Must possess unrestricted U.S. work authorization; sponsorship is not available for roles below Principal level.
Nice to have
- Experience with metal 3D-printing equipment and processes in medical applications.
- Knowledge of Six Sigma, Lean Manufacturing, Design Verification and Validation, DMAIC, and Root Cause Analysis.
- Experience with VAVE, design for inspectability, validation protocol and report creation, gauge design, and IQ/OQ/PQ.
Culture & Benefits
- Work in a mission-driven healthcare technology environment focused on improving patient outcomes.
- Health, dental, and vision insurance, plus HSA and healthcare FSA options for eligible regular employees.
- 401(k) plan with employer contribution and match, paid time off, paid holidays, and short-term disability coverage.
- Tuition assistance or reimbursement, life insurance, employee assistance, and employee stock purchase plan.
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