Job Overview

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. Leads 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. Uses critical thinking skills to solve equipment/fixture technical problems.
4. Collects and analyzes data, generates engineering reports, and proposes or completes modifications to improve the equipment/fixture functionality.
5. Provides mechanical design concepts for new equipment and fixturing to improve mfg. process capability, capacity, efficiency, cost, and quality.
6. Reviews manufacturing processes and identifies automation or fixturing improvement opportunities.
7. Drafts and executes validation of product, equipment, and processes.
8. Manages builds for new product development in prototype and pilot production settings, including training of operators and coordination with production planning.
9. Analyze data to assure robust/repeatable manufacturing processes.
10. Confers with appropriate departments, resources, and/or outside services to prepare process modifications, clarify problems and develop processes.
11. Manage process validation and product transfer activities across different manufacturing facilities and product lines.
12. Review and develop manufacturing documents (MP, Routers, BOM, Drawings, Specifications, etc.).

What your background should look like:

Skills
1. Expert in Process Validations in medical device manufacturing environment
2. Expert in statistical process analysis tools, including Design of Experiments (DOE) and Cpk for process development characterization and optimization
3. Background in laser processing (including but not limited to laser ablation, laser weld, laser marking)
4. Solid proficiency in technical documentation, including advanced CAD modeling and engineering drawings
5. Knowledge of mechanical design with SolidWorks
6. Working knowledge of conventional and CNC machining processes
7. Must have good written and verbal communication skills, be well-organized, ability to work in a fast-paced self-directed environment.

Pre-Requisition / Job Experience
1. Bachelor of Science in Engineering
2. 10-15+ years of medical device and mfg. process development experience
3. Demonstrated expertise with inferential statistical process analysis techniques
4. Demonstrated expertise with mechanical design methods using Solidworks

Competencies