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Manager, Manufacturing Engineering - Denver, United States - HireMinds
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Description
Manager, Medical Device Manufacturing Engineering
HireMinds has partnered with a leading player in the medical device industry, dedicated to improving healthcare through innovation and cutting-edge technology.
We're looking for a Manufacturing Engineering Manager experienced with implementing systems, creating new ways of work, developing a team, and operating with immature business processes.
We are growing rapidly Our fast growth is only matched by the pace at which our customers expect their new and innovative products to be delivered, so the successful candidate will have a track record of technical accomplishments in engineering that show they are able to make good technical judgments and lead technical problem-solving efforts.
This role oversees the technical support and sustaining engineering functions in a product manufacturing area. You'll implement equipment and process modifications to improve production efficiencies, manufacturing techniques, and production yields for existing products. You'll act as an engineering liaison between product design and development to ensure processes and designs are compatible. You'll select, develop, and evaluate a talented team to ensure the efficient operation.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 with sister site in Leuven, Belgium.
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.
Note:
This is an on-site role
Salary Range:
$125,000 to $145,000 per year (Salary to be determined by the education, experience, knowledge, skills, and abilities of the candidate, and alignment with market data)
In addition to a salary, this position is eligible for an annual bonus based upon company performance.
Must be a US Person for this role due to ITAR
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