4 дня назад
Production Engineer - 2nd Shift (Medical Devices)
85 000 - 115 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Production Engineer - 2nd Shift (Medical Devices): Designing and improving manufacturing processes for bionic pancreas production with an accent on production efficiency, quality compliance, and equipment performance. Focus on analyzing yield, scrap, downtime, and cycle time, solving equipment and process issues through root cause analysis, and implementing Lean manufacturing improvements in an FDA- and ISO-regulated environment.
Location: Irvine, CA; full-time onsite with regular presence on the manufacturing floor. The 2nd shift runs from 3:45 p.m. to 2:15 a.m., Monday through Thursday.
Salary: $85,000–$115,000 per year
Company
is a medical technology company developing the iLet Bionic Pancreas for type 1 diabetes management.
What you will do
- Design, develop, and implement manufacturing processes that meet product specifications and quality requirements.
- Monitor yield, scrap, downtime, cycle time, equipment performance, and other production indicators.
- Develop process improvements using Lean manufacturing principles and tools.
- Troubleshoot machinery, equipment, and software issues using root cause analysis and corrective actions.
- Coordinate concurrent production projects and collaborate with Engineering, Quality, Maintenance, Supply Chain, technicians, operators, suppliers, and customers.
- Support Good Manufacturing Practices, workplace safety, and applicable quality system requirements.
Requirements
- Bachelor’s degree in Mechanical, Manufacturing, Industrial, or Biomedical Engineering, or equivalent education and applicable experience.
- 2–5 years of relevant experience in a medical device manufacturing environment.
- Experience in medical device or consumer electronics manufacturing and FDA-, GMP-, and ISO-regulated environments.
- Knowledge of Quality System Regulation and Good Manufacturing Practice principles.
- Ability to use hand tools such as drills, soldering irons, micrometers, and calipers, and to operate electrical and mechanical equipment.
- Ability to interpret mechanical drawings, electrical schematics, and test or process results.
Culture & Benefits
- Mission-driven, collaborative startup environment with significant ownership and impact.
- Medical and dental coverage.
- FSA and HSA plan options, including an annual company HSA contribution.
- 401(k) program with employer match.
- Vacation accrual and paid holidays.
- Up to 5% travel may be required, with occasional extended hours or schedule adjustments for business and production needs.
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