Direct hire, southwest side of Rochester, 80 - 85K
A global medical device manufacturer is seeking an experienced Manufacturing Engineer to join their growing Rochester team. As the technical expert, the Manufacturing Engineer will improve production efficiency and manage equipment and automation projects through the development and implementation of Lean engineering and Six Sigma initiatives. Recent medical device or highly regulated industry experience is an absolute must, no exceptions.
- Increase production volume and improve process capabilities with a focus on maintaining and enhancing quality standards.
- Implement engineering processes and documentation protocol including requirements documents, functional and design specifications, test protocols, and summary reports.
- Carry-out test protocols through identification and resolution of non-conformances.
- Develop and execute project plans. Lead and document change control activities for several simultaneous projects.
- Assess manufacturing processes in regard to product design, creation, assembly, tooling, and materials. Consult with vendors and operators.
- Perform root cause analysis to assess risk to ensure the safe and quality delivery of products.
- Analyze and plan work flow, space requirements, and equipment layout to improve manufacturing efficiency.
- Lead the implementation of new product production.
- Bachelor’s degree in Mechanical or Manufacturing Engineering or a related field required.
- 5+ years’ experience in a highly regulated manufacturing environment required, preferably medical devices.
- Knowledge of quality system standards, including ISO 9000 and 13485, FDA CFR for medical devices, pharma, and food safety.
- Demonstrated ability to implement and lead continuous improvement efforts, such as Kaizen, 6S, and visual management.
- Demonstrated project management skills.
- Hands-on experience working with machinery.
- Strong leadership abilities and communication (verbal and written) skills.
- Strong computer skills, specifically with MS Excel, CAD, and SPC.
This position is not eligible for Visa sponsorship.