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EI
E-Solutions Inc.
Sr Manufacturing Engineer
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What they do
A Manufacturing Engineer uses technology and engineering to help companies and organizations manufacture products with efficient use of time, resources, and energy.
$95,400 / year median in Connecticut
-2% projected decline
Job Description
Sr Manufacturing Engineer (North Haven, CT) | 08/31/26
Job Description Job Description & Skill Requirement:
- Support Medtronic's Surgical Innovations manufacturing operations in North Haven, CT by ensuring the highest standards of product quality and regulatory compliance.
- Develop, implement, and maintain quality standards, protocols, and procedures for manufacturing processes and finished medical device products.
- Partner closely with Manufacturing, Operations, and Engineering teams to improve process performance, enhance product reliability, and drive continuous improvement initiatives. Lead process validation activities, perform root cause investigations, manage CAPA and non-conforming material activities, conduct statistical analysis, and support inspection and testing strategies.
- Ensure documentation compliance and adherence to FDA, ISO, and internal quality management system requirements.
Qualification:
- Bachelor's Degree in Engineering, Science, Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or related technical discipline.
- Typically 7+ years of experience in Engineering and/or Quality Engineering, preferably within medical device or regulated manufacturing environments.
- Strong expertise in process validation throughout the validation lifecycle.
- Experience with CAPA, NCMR, root cause investigations, and quality system requirements.
- Knowledge of statistical analysis tools (e.g., Minitab) and risk-based decision making.
- Experience with