Responsible for supporting medical devices for both existing and new product development, production, and processes. This includes creating or verifying specifications, maintaining, and enhancing product processes, and designing fixtures and equipment, testing processes, equipment, test methods, and raw materials to ensure that the concepts and prototypes meet their specifications. Lead and support projects related to new product introductions, process development engineering, quality systems im... more details
Responsible for supporting medical devices for both existing and new product development, production, and processes. This includes creating or verifying specifications, maintaining, and enhancing product processes, and designing fixtures and equipment, testing processes, equipment, test methods, and raw materials to ensure that the concepts and prototypes meet their specifications. Lead and support projects related to new product introductions, process development engineering, quality systems improvement, and other engineering tasks. Evaluate, initiate, and establish improved engineering and project systems for procurement and execution of process validation. Job duties:
Provide manufacturing support for existing processes, new products, product changes, line extensions, enhancements, and related tooling and fixtures.
Support validation of product, equipment, and processes.
Collaborate with other departments to ensure readiness for process validation.
Draft and execute validation of product, equipment, and processes.
Evaluate, create, and initiate improvements to existing engineering and project systems.
Manage builds for new product development in prototype and pilot production settings, including training of operators and coordination with production planning.
Confer with appropriate departments, resources, and/or outside services to prepare process modifications, clarify problems, and develop processes.
Set up and initiate new manufacturing line(s), including purchasing, implementing, and validating new equipment.
Review and develop manufacturing documents (e.g., MP, BOM, pFMEA, etc.).
Develop documentation expertise in equipment mechanical design and manufacturing processes.
Seek and implement innovative technologies to enhance manufacturing processes and equipment design.
Lead, mentor, and support Engineers, Technicians, or others as needed.
Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
Perform additional duties as assigned.
Bachelor's degree in Mechanical/Manufacturing/Industrial Engineering or related field.
A minimum of six (6) years of relevant manufacturing process development experience in the medical device industry.
Strong written and verbal communication skills.
Proficient computer skills including MS Word, Excel, Outlook, Teams, and CAD.
Desired Qualifications
Advanced degree in Engineering or related field.
A minimum of eight (8) years of relevant manufacturing process development experience in the medical device industry.
Ability to design, develop, and validate manufacturing processes of medical devices and working knowledge of cGMP.
Knowledge of statistical tools including Design of Experiments (DOE) and Cpk for process development, characterization, and optimization preferred.
Proven knowledge of Lean/Six Sigma techniques (Green or Black Belt a plus).
Ability to solve complex manufacturing problems.
Ability to read and prepare technical documentation.
Knowledge of medical and technical development as well as international regulations for medical devices.
Strong problem solving and conflict management skills.
Proficiency with SolidWorks and fixture design preferred.
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