Job Overview

TE Connectivity's Manufacturing & Process Development Engineer role supports manufacturing of products for medical devices with work including writing or verifying specifications, maintaining product process, designing fixtures, test processes, equipment and raw materials to ensure that the subassemblies and finished products meet their requirements. Work closely with R&D, Quality, and Regulatory in supporting the development of new products and manufacturing processes to achieve a smooth, successful transfer to Manufacturing Engineering and production launch.

Primary Responsibilities

1. Assists in projects related to tooling, fixtures, or equipment implementation for new manufacturing processes, new products, and existing manufacturing process enhancements.
2. Articulates equipment/fixture design requirements to in-house and outside design teams, manages equipment/fixture builds, and develops the unit to work properly for the manufacturing process.
3. Collects and analyzes data, generates engineering reports, and proposes or completes modifications to improve the equipment/fixture functionality.
4. Drafts and executes validation of product, equipment, and processes.
5. Analyze data and improve processes to assure robust/repeatable manufacturing processes.
6. Confers with appropriate departments, resources, and/or outside services to prepare process modifications, clarify problems, and develop processes
7. Manage process validation and product transfer activities across different manufacturing facilities and product lines
8. Review and develop manufacturing documents (MPI, IQOQ, BOM, Drawings, Specifications, etc.)

Skills

1. Expert in Process Validations in medical device manufacturing environment
2. Understanding if statistical process analysis tools, including Design of Experiments (DOE) and Cpk for process development characterization and optimization
3. Proficiency in technical documentation, including CAD modeling and engineering drawings
4. General knowledge of mechanical design with Solidworks
5. General knowledge of conventional and/or CNC machining processes
6. Must have good written and verbal communication skills, be well-organized, ability to work in a fast-paced self-directed environment

What your background should look like:

Pre-Requisition / Job Experience

1. Bachelor of Science in Engineering
2. 0-2 years of medical device and mfg. process development experience
3. Demonstrated knowledge with inferential statistical process analysis techniques
4. Demonstrated knowledge with mechanical design methods using SolidWorks

Physical Requirements

1. Extended periods of sitting or standing
2. Extended periods of working in a cleanroom environment
3. Ability to lift up to 35 pounds
4. Extended periods of computer usage

Competencies