Engineer II, NPI & Transfer

Job Description

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. Support projects related to new product introductions, process development engineering, quality systems improvement, and other engineering tasks. Evaluate, initiate, and establish improved engineering and process validation. Job duties:

• Support new and existing manufacturing processes, new products, product changes and enhancements, as well as related tooling and fixtures.
• Draft and execute validation of product, equipment, and processes.
• Provide mechanical design concepts for new equipment and fixturing to improve manufacturing process capability, capacity, efficiency, cost, and quality.
• Lead builds for new product development in prototype and pilot production settings, including training of operators and coordination with production planning.
• Analyze data and improve processes to assure robust/repeatable manufacturing processes.
• Confer with appropriate departments, resources, and/or outside services to prepare process modifications, clarify problems, and develop processes.
• Support projects related to process validation and product transfer activities across different manufacturing facilities and product lines.
• Develop manufacturing documents (e.g., MP, Routers, BOM, Drawings, Specifications, etc.).
• Develop and maintain project timelines, milestones, and deliverables to ensure smooth execution of the NPI process.
• Collaborate with the quality team to establish testing and inspection protocols to ensure the final product meets quality standards.
• Collaborate with design engineers to optimize product designs for efficient manufacturing and assembly processes.
• Review product designs to identify potential manufacturability and assembly issues, providing recommendations for improvements.
• 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.

Qualifications

Bachelor of Science degree in Engineering or a related field.

A minimum of two (2) years of relevant manufacturing process development experience.

Demonstrated expertise with inferential statistical process analysis techniques.

Demonstrated expertise with mechanical design methods using SolidWorks.

Strong written and verbal communication skills, organizational skills, and ability to work in a fast-paced, self-directed environment.

Proficient with MS Word, Excel, Teams, and Outlook.

Desired Qualifications

A minimum of four (4) years of relevant manufacturing process development experience.

Experience in Process Validations in medical device manufacturing environment.

Experience in statistical process analysis tools, including Design of Experiments (DOE) and Cpk for process development characterization and optimization.

Solid proficiency in technical documentation, including advanced CAD modeling and engineering drawings.

Demonstrated expertise related to mechanical design of manufacturing equipment, fixturing, and tooling.

Experience with Six Sigma or Lean methodologies is advantageous.

Excellent problem-solving skills and ability to work in a dynamic environment.