Technical Transfer Engineer-Manufacturing/Mechanical
Orange County Metro Area, CA
- The Technical Transfer group operates in a matrix organization to transfer designs, products, technologies, equipment, and acquired company assets to the site and where applicable into production at the site
- The technical transfer engineer is the primary contact on the transfer team and ensures that there is sufficient representation from the impacted areas.
- The technical transfer engineer establishes appropriate team roles and responsibilities for activities at the site they represent
- The technical transfer engineer works with the Core Team and assists in the creation of plans, actively creates technical transfer deliverables
- The technical transfer engineer engages the MTO and MS&T resources, guides them and coordinates the day to day activities that culminate in a successful transfer of the product, process, or project into the manufacturing environment
- The technical transfer engineer works closely with R&D, purchasing, planning, line supervisors, quality engineers, and supervises/monitors and completes of all transfer activities
- The technical transfer engineer works under the guidance and reports to the Technical Transfer Lead
- The technical transfer engineer coordinates activities, reviews work product (design, documentation, validations, data) of temporary engineering staff, technical stewards, and validation engineers that are assigned to the product, process, or project being transferred
- The technical transfer engineer participates in design reviews and engages the appropriate subject matter experts to ensure designs can be manufactured to specification, yield, reliability, and cost
- 5 years experience in industry. Medical device manufacturing/process engineering preferred
- 1-2 years experience in new product introductions/manufacturing/ manufacturing science and technology/technical development/quality/R&D
- In depth understanding of manufacturing processes and related process equipment
- Experience with equipment qualifications and process verifications/validations (IQ,OQ, PQ)
- Experience utilizing CAD software (Creo, ProE, Solidworks) and design of production fixtures and equipment
- Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities
- 1-2 years of experience in executing process validation, transfer of products from R&D into manufacturing, and working on multidisciplinary teams that include all functions in the manufacturing environment
- Fluent in English
- Specific experience in PCB manufacturing and design.
- This person must be able to critique designs for their manufacturability and provide feedback to the team.
- Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions)
- REQUIRED: BSC. in Engineering
- PREFERRED: Master of Science in Engineering