Medical Device Engineer II
6 days ago
We are seeking a highly skilled Medical Device Engineer II to join our team at Agiliti Health. As a key member of our quality assurance team, you will play a critical role in ensuring the quality and safety of our medical devices.
About the Role:
- Develop and implement quality engineering systems and practices to ensure compliance with regulatory requirements.
- Collaborate with cross-functional teams to identify and address quality issues.
- Maintain accurate records of product control plans, inspection methods, and supplier performance data.
- Analyze supplier performance data to detect trends and address any deviations or issues.
Qualifications:
- Bachelor's Degree in Engineering, Scientific, or Technical related subject required.
- 3-5 years of relevant experience, preferably in a medical device manufacturing environment.
- Working knowledge of New Product Development.
- Experience in FDA 21 CFR Part 820 Quality System Regulation and ISO 13485:2016 Medical Devices required.
Benefits: We offer a competitive salary range of $87,085.99 - $139,463.03 per year, as well as a comprehensive benefits package including health insurance, short- and long-term disability plans, flexible spending accounts, life insurance options, paid time off, 401(k) savings plan with employer match, employee discounts, tuition reimbursement, daily pay program, employee assistance program, and wellness programs.
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