Intake Notes:

• Engineering professional individual contributor with comprehensive knowledge in the area of Manufacturing Process and Process Development.
• Ability to execute highly complex or specialized projects.
• Performs analyses to develop design specifications and performance requirements.
• Provides technical information concerning manufacturing or processing techniques, materials, properties and process engineering planning
• Ability to establish processes based on product specifications
• Evaluate process and design alternatives based on Design for Manufacturability principles.
• Develops procedures for the economical mass production in cooperation with pilot and production departments
• Services, troubleshoots and solves production process problems with processes or equipment already in operation Experience
• Experience in designing and developing manufacturing processes for medical device products, or similar, taking into consideration problems inherent in the transfer of technology from research to manufacturing
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.  
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Minimum 5 years experience in NPI, NDP, New Product Development focused on process development, documentation and validation.

Experience: 

• Minimum 5 years, preferably senior level.

•  Transitioning products from R&D to production.
•  Conducting pilot builds and device verification.
•  Performing testing builds.
•  Implementing FDA/ISO medical device process validation.

• Equipment IQ/OQ/PQ.
• Knowledge of ISO 13485 and FDA 21 CFR Part 820.
• Experience in thermoplastics injection molding.

• Bachelor's degree in manufacturing, industrial engineering, or mechanical engineering.
  
  

• Cable assembly expertise (extrusion, cabling, braiding, shielding, connector termination).
• Hands-on collaboration in a cross-functional team environment.
• Designing and developing manufacturing processes.
• Document writing/editing, including process documentation.
• Reviewing process tooling and specifications.
• Understanding geometric dimensioning and tolerancing.
• Background in NPI and new product development.
• Medical device manufacturing experience.
• Materials background, especially in thermoplastics.