Engineering Manager will be responsible for Engineering, Design Controls, EHS&S, Maintenance and Facility governance.
- Develop a high performing team through empowerment and accountability.
- Ensure the performance of all direct reports is evaluated to maximize their performance and development throughout the year and during the annual performance review.
- Develop staff by setting SMART goals, driving a culture of accountability.
- Provide mentorship and coaching to the Maintenance and Engineering departments to ensure work is performed in accordance with documented specifications and SOP’s.
- Identify and implement new technologies and automation through digital transformation and SCADA integration
- Maintain, develop, and optimize key processes to reduce costs, improve quality, and increase machine utilization and efficiency, ensuring all aspects of equipment operations are safe and compliant.
- Function as a technical resource.
- Lead the design, procurement, validation, and installation of new and upgraded manufacturing process equipment.
- Lead the design and development of new products
- Manage the Design Control Program for new, unique, or customized medical devices and/or the processes for their realization.
- Establish, review and approve engineering drawings; product, process or equipment specifications and Engineering Change Orders (ECO’s)
- Manage the PPAP process to qualify new components, suppliers and/or modified mold tooling.
- Develop strong relations with key vendors/suppliers
- Bachelor's Degree in Engineering.
- Professional Engineer designation preferred.
- 10 years of experience in manufacturing plant engineering. Assembly and packaging experience preferred.
- Previous experience in an FDA and/or ISO 13485 environment required.