Our client specializes in additive manufacturing to offer a range of precision healthcare solutions. They are looking for a skilled Manufacturing Engineering Manager who is experienced with implementing systems, creating new ways of work, developing a team, and operating with immature business processes.
Responsibilities:
Manage project portfolio: Create and manage project portfolio for all engineers in Operations. Balance urgent needs with long term improvements. Coordinate projects that affect worldwide manufacturing.
Drive Scrap Reduction: Use existing scrap tracking information to analyze data, identify opportunities for improvement, and lead cross-functional efforts with Quality, Production, and Manufacturing Engineering to reduce scrap.
Lead customer account management: Lead customer project meetings and manage internal efforts to implement changes as needed. Lead complaint investigations, negotiate changes to support operational improvements, and coordinate with stakeholders to optimize quality, capacity, and cost.
Improve Manufacturing Processes and Implement Automated Solutions: Guide the Manufacturing Engineering team in selection and implementation of new manufacturing processes and equipment that will improve output, consistency, and yields. Ensure new processes are appropriate with regard to safety, quality, cost, capability, facilities requirements, and future scalability.
Improve project quality through Design Transfer: Reduce early lifecycle scrap and rework by ensuring that proper manufacturing engineering is done in Development. Partner with business development engineers to improve product and manufacturing process development.
Develop staffing plan: Plan for engineering support of all operations. Implement contingencies, communication channels, ways of work, and, ultimately, engineering staff to support this plan.
Establish Post Processing Capacity: Evaluate capacity of existing key post-printing processes (both internal and outsourced) and establish plan to meet current and future demands. Partner with Supply Chain and Facilities and guide manufacturing engineers to improve efficiencies so that capital expenditures are optimized.
Maintain and Improve DMRs: Guide the team in the creation, maintenance, and consistent use of DMR documentation and visual work instructions. Collaborate with production, IT and quality teams to implement or improve systems.
Qualifications
Bachelor's degree in engineering or a related field; or equivalent combination of education and experience. Master's degree preferred.
Substantial background in the medical device industry and extensive knowledge of process validation as well as FDA 21 CFR Part 820, ISO 13485, and/or ISO 14971 is required.
Technical experience in any of the following areas desirable: additive manufacturing, CNC machining, heat treating, mass finishing, cleaning, packaging, sterilization, and/or manufacturing software implementation.
Demonstrated experience in project management, program management, and portfolio management required.
Having worked in a matrixed, cross-functional environment highly beneficial.
As a manufacturer with aerospace and defense customers under ITAR, candidate must be a US person.
This is an onsite role, generally Monday through Friday, with infrequent travel.