The Engineering Manager, Process Engineering reports to Global Manager, Manufacturing Process Development Engineering.
The successful candidate is highly technical, must be hands-on, and will lead engineers with entry/junior level to senior level experience in researching new ideas/technologies. Responsible for resolving technical engineering issues, as a priority, and generating accompanying project plans. Leads process and equipment development activities such as developing specifications, designing fixtures, and conducting controlled studies to ensure that product subassemblies and finished products meet their design requirements. Works closely with R&D, Quality, and Regulatory in leading the development of new fixtures, equipment, products, and manufacturing processes to achieve a smooth, successful transfer to Manufacturing Engineering for manufacturing production launch.

The successful candidate will:

• Manages process validations and tooling/ fixture/ equipment implementations across different manufacturing facilities and product lines
• Analyzes and/or directs the evaluation of test data to assure the development of robust/repeatable fixtures, equipment, and new products.
• Confers with appropriate departments, resources, and/or outside services to prepare process modifications, clarify problems, and develop processes.
• Reviews and develops validation and/or manufacturing documentation (Technical Drawings, Specifications, Protocols, Reports, Software Validation, etc.)
• Reviews and develops mechanical design concepts for new equipment and fixturing to improve mfg. process capability, capacity, efficiency, cost, and quality
• Leads a group of individuals of varying technical experience from entry level to junior level on projects of defined scope and diversity.
• Directs subordinates towards clear company objectives in an efficient and effective manner.
• Collaborates with all departments and other employees associated to Process Development Engineering to achieve company objectives and resolve project issues.
• Communicates project status and issues in a timely, clear, and appropriate manner to the organization.
  

What your background should look like:

• Bachelor of Science in Engineering
• 10+ years of medical device and mfg. process development experience (for Staff Engr and Manager level)
• 5+ years of managing a team of engineering professionals (for Manager level only)
• Lean Six Sigma Black Belt or equivalent certification
• Demonstrated expertise with inferential statistical process analysis techniques
• Demonstrated expertise with mechanical design methods using Solidworks
• Expert in Process Validations in medical device manufacturing environment
• Expert in statistical process analysis tools, including Design of Experiments (DOE) and reliability/capability for process development characterization and optimization
• Solid proficiency in technical documentation, including advanced CAD modeling and engineering drawings
• Working knowledge of conventional and CNC machining processes
• Must have good written and verbal communication skills, be well-organized, ability to work in a fast-paced self-directed environment
  

Physical Requirements:

• Extended periods of sitting or standing
• Extended periods working in a cleanroom environment
• Ability to lift up to 35 pounds
• Extended periods of computer usage