Manufacturing Engineering Manager
Location: Sarasota, FL
Summary of Functions:
Leading the Manufacturing Engineering team, the Manufacturing Engineering Manager will support transfer of newly developed products into manufacturing, lead industrialization of production lines from a technical perspective, deployment of capital equipment (CNC Mills, Lathes, Swiss Screw Machines, Wire EDMs, etc.), lead development of manufacturing processes and scale-up activities to support the Operations team:
- Working closely with the R&D Engineers, supporting the Design Transfer activities for products entering production.
- Leading process improvement teams on existing production lines and supporting redesign activities to enable optimal manufacturability and performance.
- Providing leadership support to the manufacturing teams enabling high yield production through process development, statistical process control, lean-six sigma activities, instilling a culture of Continuous Improvement and Operational Excellence.
- Development and maintenance of Inspection Guide Sheets, work instructions and routings for production, development and optimization of process flow diagrams, pFMEAs, optimization of production records and support of Manufacturing systems and Equipment.
- Providing training and guidance regarding manufacturing processes to engineers and machinists; leading that team that troubleshoots equipment and processes from a Technical Operations / Engineering perspective.
- Provide programming, programming guidance and training to manufacturing engineers and machinists to insure proper operation of multi axis CNC turning and milling centers.
Participates in all aspects of design and development of new products and changes to existing products including, but not limited to:
- Leading the team that generates process and design documentation for products entering production or as part of lifecycle management / sustaining engineering.
- Leading the installation qualifications (IQ), operational qualifications (OQ), and performance qualifications (PQ) for manufacturing and injection molding equipment.
- Leading the team responsible for product inspection and verification methods, development of process controls and methods and troubleshooting existing inspection and verification methods.
- Leading that team that supports Operations with document control and technical documentation as necessary.
This position reports to the Vice President and General Manager, Sports Medicine
Major Duties and Responsibilities/Authority:
- Leading the team that develops manufacturing processes in order to optimize output, increase quality, while minimizing cost.
- Leading the manufacturing engineering functions to develop work instructions for manufacturing processes.
- Provide guidance and training of machine programming and set-up to various members of Operations.
- Monitoring and analyze process control and variation. Using statistical techniques, lean/six-sigma, kaizens, and Total Quality Management determine when changes are necessary to improve quality and lead the implementation of process improvements;
- Lead the team that generates, reviews, and monitors control and validation activities.
- Working to become a champion of safety and quality ensuring that specific considerations and requirements are pro-actively addressed and implemented in product production processes.
- Generating, reviewing, and/or approving product documentation including, but not limited to, design documentation (e.g. design plan, design inputs, etc.), drawings/prints, inspection procedures, protocols, reports, labeling, risk management documentation (e.g. risk management plan, risk analysis, etc.), deviation requests, and assist with regulatory submissions;
- Participate in the maintenance of the Design History File (DHF), Risk Management File, Device Master Record (DMR), and Technical File as necessary from a Technical Operations perspective.
- Supporting design related issues in production (e.g. nonconformances, customer complaints, etc.).
- Project management and training as necessary.
- Leading the timely resolution of safety and quality issues raised by customers or staff.
- Supporting Quality System and Safety and Health Program by following procedures, advising others, and working in partnership with the Quality Manager / Director and EHS Manager / Director to enable a Quality and Safety focused culture.
- Ability to work at a desk and stand for extended periods of time (2 hrs)
- The employee might be frequently required to climb stairs, kneel, or crouch, in accordance with job duties;
- Ability to lift up to 30lbs.
Experience and/or Educational Requirements:
- Engineering degree, preferably Mechanical;
- 5+ years minimum industrial experience in a Medical Device industry supporting Operations teams as a Manufacturing Engineer; 5+ years’ experience with machining or molding operations preferred.
- Strong manufacturing and programming experience with multi axis CNC equipment.
- Injection molding experience.
- Track record of industrializing medical devices at production volume levels of 50-1,000 units per batch, molding, machining, screw-machining, sand blasting, deburring experience preferred
- Experience with or ability to learn Statistical Analysis Methodology such as Six Sigma or LEAN;
- Experience with or ability to learn MS Office, SolidWorks and/or other CAD/CAM packages, and inspection/testing software;
- Medical experience and/or familiarity with FDA QSR’s and ISO 13485 desirable.
We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.