Job Details

Job Responsibilities:

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

Key Qualifications:

1. Minimum 5 years experience in NPI, NDP, New Product Development focused on process development, documentation and validation.
2. Engineering professional individual contributor with comprehensive knowledge in the area of Manufacturing Process and Process Development.
3. Ability to execute highly complex or specialized projects.
4. Performs analyses to develop design specifications and performance requirements.
5. Provides technical information concerning manufacturing or processing techniques, materials, properties and process engineering planning.
6. Ability to establish processes based on product specifications.
7. Evaluate process and design alternatives based on Design for Manufacturability principles.
8. Develops procedures for the economical mass production in cooperation with pilot and production departments.
9. Services, troubleshoots and solves production process problems with processes or equipment already in operation.
10. 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.
11. Ability to work in a highly matrixed and geographically diverse business environment.
12. Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
13. Ability to leverage and/or engage others to accomplish projects.
14. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
15. Multitasks, prioritizes and meets deadlines in a timely manner.
16. Strong organizational and follow-up skills, as well as attention to detail.

Skills:

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

Education:

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

Preferred Skills:

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