Participate on cross-functional project teams including R&D, Quality Assurance, Supplier Quality, Planning, Purchasing, Regulatory, and Manufacturing to maintain and improve surgical products
As a recognized manufacturing process technical expert who can provide engineering knowledge and oversight to resolve manufacturing- and quality-related problems with existing products.
Support and lead manufacturing process improvements for CSS products in both internal manufacturing facilities and in partnership with external suppliers.
Provide project leadership to improve existing products and associated manufacturing processes.
Design, specify, develop and procure manufacturing tooling, fixtures and equipment, and will lead the implementation and validation of such manufacturing processes and equipment.
Support the selection and validation of replacement materials, such as polymers, metals, and adhesives, for CSS applications.
Write and revise assembly procedures and work instructions for manufacturing, and provide the oversight to implement such procedures.
Identify and provide innovative new manufacturing technologies from industry best practices that can be applied to CSS products.
Represent the Manufacturing Engineering group on strategic projects in manufacturing and sourcing.
Minimum of a Bachelor’s degree in Mechanical, Manufacturing, Materials or Biomedical Engineering with a minimum of 6 years of relevant experience or a Master’s degree in Engineering with 5 years of relevant engineering experience is required.
Medical device industry experience is preferred.
Knowledge of how to execute GMPs, ISO 13485 Design Control, and manufacturing process IQ, OQ, PQ qualifications as related to medical devices is required.
Knowledge of Six Sigma Process Excellence is preferred, Black Belt certification is preferred.
Knowledge in manufacturing processes such as polymer processing (molding, compounding, extrusion, fusing), metal processing (machining, laser cutting, polishing, welding), assembly, equipment & tool design is required.
Knowledge of Design for Manufacturability in plastics, metals and small scale assembly processes is preferred.
Knowledge of financial accounting and analysis methods to assess product standard costs, project values, cost improvements and capital purchases is preferred.
Leadership experience in managing technical relationships with external suppliers and OEMs is required.
Strong communication, team building, and cross-functional coordination skills are required.
This position is to be located in Mansfield, MA and may require up to 10% travel, including international.