8 дней назад
Manufacturing Engineer 2 - POC Meters (Medical Devices)
100 000 - 130 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Manufacturing Engineer 2 - POC Meters (Medical Devices): Supporting the manufacturing of point-of-care meters through equipment and process development, validation, documentation, and production-floor problem solving with an accent on IQ/OQ/PQ/VQ qualification, quality systems, and process reliability. Focus on transferring new products to manufacturing, investigating production issues, training operators, and improving cost, cycle time, and quality.
Location: On-site five days per week at 165 Lexington Road, United States
Salary: $100,000–$130,000 per year
Company
develops and manufactures point-of-care, biotechnology, osmolality testing, and in vitro diagnostic instrumentation for clinical and biopharmaceutical applications.
What you will do
- Provide technical support for point-of-care meter manufacturing operations.
- Develop, design, validate, and improve manufacturing equipment, processes, and production tools.
- Create and update manufacturing documentation, including drawings, bills of materials, assembly and test procedures, operating instructions, and quality-system records.
- Write and execute IQ, OQ, PQ, validation, DOE, PFMEA, and process master validation activities.
- Investigate manufacturing issues and support product transfers in collaboration with R&D and other functions.
- Train assemblers and operators and contribute to improvements in cost, cycle time, process reliability, and product quality.
Requirements
- 3–5 years of experience in a manufacturing environment, preferably medical manufacturing.
- Experience with manufacturing documentation and processes governed by QSR and ISO standards.
- Ability to perform technical floor support, engineering studies, process validation, and continuous improvement activities.
- Ability to lift 20 pounds and sit or stand for extended periods.
- Must work on-site five days per week.
Culture & Benefits
- Medical, dental, and vision coverage.
- 401(k) company match, bonus program, generous paid time off, and paid holidays.
- Tuition reimbursement and professional development opportunities.
- Flexible work arrangements are available within the company, while this role requires five days on-site.
- Lunch and snack marketplace or subsidized cafeteria options at selected offices.
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