Job Description

Responsible for supporting process development and improvements for medical devices for both existing and new product development, production, and processes. This includes working closely with R&D at the early phases of product development to create manufacturing specifications, maintain, and enhance product processes, and design fixtures and equipment, testing processes, equipment, and validate test methods, and select raw materials to ensure that the concepts and prototypes meet their specifications. Support projects related to new product introductions, existing process improvement and engineering to improve product quality and yields, and other engineering tasks. Evaluate, initiate, and establish improved engineering and project systems for procurement and execution of process validation. Work with Manufacturing, Quality, Regulatory, and global Marketing teams internally and outside vendors and consultants.

1. Develop new processes and perform process characterization and optimization
2. Support improvement for existing processes, new products, product changes, line extensions, enhancements, and related tooling and fixtures
3. Work closely with R&D team to design manufacturability and assembly into the product (dFMEA)
4. Characterize process and determine critical process parameters by applying statistical tools such as DoE and ensure readiness for process validation
5. Apply statistical process control techniques to establish review and refine control limits for existing processes
6. Support validation of product, equipment, and processes
7. Collaborate with other departments to ensure readiness for process validation
8. Draft and execute validation of product, equipment, and processes
9. Evaluate, create, and initiate improvements to existing engineering and project systems
10. Analyze test data using statistical tools (e.g., Minitab) to inform leadership decisions for enhancing existing processes and improving product quality and yield
11. Manage builds for new product development in prototype and pilot production settings, including training of operators and coordination with production planning
12. Plan and execute root cause investigations related to product and process failures
13. Confer with appropriate departments, resources, and/or outside services to prepare process modifications, clarify problems, and develop processes
14. Set up and initiate new manufacturing line(s), including purchasing, implementing, and validating new equipment (IQ/OQ)
15. Support Design Transfer and Line Transfer activities to different manufacturing sites
16. Review and develop manufacturing documents (e.g., MP, BOM, pFMEA, etc.)
17. Develop documentation expertise in equipment mechanical design and manufacturing processes
18. Seek and implement innovative technologies to enhance manufacturing processes and equipment design
19. Help establish systems for monitoring production processes to identify inefficiencies and develop strategies to reduce waste, improve yield, and enhance product quality
20. Lead, mentor, and support Engineers, Technicians, or others as needed
21. 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
22. Perform additional duties as assigned

Qualifications

1. Bachelor's degree in Mechanical/Manufacturing/Chemical/Industrial Engineering or related field
2. Minimum six (6) years of relevant manufacturing process development experience in the medical device and/or pharmaceutical industry
3. Strong written and verbal communication skills
4. Proficient computer skills including MS Word, Excel, Outlook, Teams and CAD

Desired Qualifications
1. Advanced degree in Engineering or related field
2. A minimum of eight (8) years of relevant manufacturing process development experience in the medical device and/or pharmaceutical industry
3. Proven ability to design, develop, and validate manufacturing processes of medical devices and working knowledge of cGMP
4. Knowledge of statistical tools including Design of Experiments (DOE) and Cpk for process development, characterization, and optimization preferred
5. Knowledge of process design, optimization and validation (IQ, OQ, PQ)
6. Familiarity with statistical tools (e.g., Minitab)
7. Proven knowledge of Lean/Six Sigma techniques (Green or Black Belt a plus)
8. Ability to solve complex manufacturing problems
9. Demonstrated ability to improve process capacity and improve yield
10. Ability to read and prepare technical documentation
11. Knowledge of medical and technical development as well as international regulations for medical devices
12. Strong problem solving and conflict management skills
13. Proficiency with SolidWorks and fixture design preferred

Salary Range

$116,706.01-$145,882.52 (Financial compensation packages may be higher/lower than listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand)