The Manufacturing Engineering Manager will provide purpose, direction, and motivation while operating to accomplish the goals and improving the Manufacturing Engineering Group. They will provide guidance and expertise towards the final stage development, scale up, and commercialization of new and existing product lines and tooling for Polymer, Device and Natural Material COE’s.
Requirements
- Extensive knowledge and experience working with products/processes used in medical device environment.
- Proficient in the use of MSOffice, Word, Excel, PowerPoint, MS Project, IYlinitab, and SharePoint.
- Extensive knowledge and experience working with manufacturing machinery and tooling in a medical device environment or related industry.
- Extensive knowledge and experience working with Engineering & Quality tools (Statistics, Lean Six Sigma, DFM, DOE).
- Knowledge and experience working with the Regulatory pathways associated with IDE, 510k, PMA, & CE including the associated ISO & ASTM standards.
- Broad and comprehensive knowledge of engineering theories, concepts and practices with the ability to use these in complex, difficult and/or unprecedented situations.
- Excellent analytical, problem solving and decision-making skills to choose the best solution and solve problems as decisions may have major implications.
Responsibilities
- Manage evaluation of scale up options, selection, & implementation by leading projects, providing project updates, and offering input for the next phases.
- Manage evaluation of potential new product/ process proposals and provide recommendations as to the scope and necessary timing required for specific production targets.
- Develop and review project plans, cost estimates, schedules, and resource requirements.
- Lead Manufacturing Reviews of new products and process improvements.
- Cultivate a team with the expertise to provide in-house development and/or technical leadership to Research & Development, Commercialization, and Operations Groups.
- Manage continuous improvement of products/ processes to achieve improvements in productivity, yield and/or operating costs.
- Manage the preparation of applicable technical sections of regulatory documents (FDA 510k, IDE, PMA, CE), grants, & patent filings.
Other
- Manage evaluation of scale up options, selection, & implementation by leading projects, providing project updates, and offering input for the next phases.
- Manage evaluation of potential new product/ process proposals and provide recommendations as to the scope and necessary timing required for specific production targets.
- Develop and review project plans, cost estimates, schedules, and resource requirements.
- Lead Manufacturing Reviews of new products and process improvements.
- Cultivate a team with the expertise to provide in-house development and/or technical leadership to Research & Development, Commercialization, and Operations Groups.
