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Engineer II- Design Transfer in Santa Barbara, CA , at Arthrex
Engineer II- Design Transfer
INC Santa Barbara, CA
Main Objective: Responsible for full support of all new product development Design Transfer activities for cost effective and QMS compliant transfer of product design specifications (dimensional, cosmetic, functional), to full scale internal or external manufacturing production.
Essential Duties and Responsibilities:
- Fully understand external regulatory and internal QMS requirements for Design Transfer.
- Review product specifications prior to finalization and recommend alterations to Product Development Engineering to improve cost, clarify requirements, establish practical inspection methodologies, and improve overall manufacturability of products.
- Facilitate effective and efficient transfer of product design specifications and functional/cosmetic requirements from New Product Development to manufacture of production equivalent samples and, subsequently, full scale production.
- Work with Product Development Engineering to identify design transfer issues and risks. Establish plans or activities for risk mitigation.
- Interact with Arthrex Manufacturing and/or external suppliers for the accurate transfer of design specifications and functional/cosmetic requirements.
- Coordinate procurement of production equivalent product for design verification and validation activities.
- Determine and adhere to budgets and timelines for assigned projects.
- Provides required Design Transfer documentation for inclusion in the Design History File for assigned projects, adhering to Arthrex Design Control procedures.
- Support Arthrex Manufacturing and/or external suppliers during scale up of manufacturing and/or inspection activities for new product launches.
- Determine necessary inspection criteria for verification of critical dimensions, features, and/or functions in order to safeguard original design intent.
- Report progress and status of assigned projects on a timely basis.
- 10-15% travel (domestic and international) may be required.
Knowledgeable of FDA and ISO guidelines for the development of medical devices required.
Manufacturing and inspection process knowledge preferred.
Project management and communication skills training preferred.
3 years experience with BS or MS degree in Engineering required (Manufacturing. Mechanical, Industrial or Biomedical preferred).
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.