Join our team in CT! TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a highly motivated Principal Application Engineer to join our organization. TOMZ offers competitive compensation and excellent benefits, including 401k, health/dental, vision and paid time off. TOMZ maintains a modern, clean, and safe facility with state-of-the-art equipment and dedication to continuous process improvement. TOMZ is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and is certified to ISO 13485.

SUMMARY OF POSITION:

Reporting to the Applicaitons Manager, this position will have direct responsibility for key production-related deliverables including but not limited to Manufacturing plan; Capacity planning; COGS estimation; Process validations; Capital equipment specifications and procurement; Production line set-up, as well as coordinate the launch of new products into production. TOMZ manufactures parts via high precision metal machining, finishing, assembly, and anodize processes for Medical Devices.

ESSENTIAL FUNCTIONS:

• This position may have direct-reporting responsibilities for daily activities of site Engineering personnel (responsibility dependent on geographic organizational structure).
• Develop and perform installation, operational and process qualifications for customer manufacturing processes in cooperation with cross-functional engineering teams per project requirements.
• Ability to program various pieces of CNC equipment across multiple sites as directed to support critical and/or high-value projects milling, turning, and grinding, Multi spindle, Multi Axis and Swiss style programs for manufacture of medical devices- implants and instruments.
• Analyze drawings, design models, and sketches to determine dimensions and configuration of cuts, selection of cutting tools, machine speeds, and feed rates according to shop processes, customer specifications, and machine capabilities
• Actively participate in process development projects and DFM with internal and external teams
• Revise programs to eliminate instruction errors, omissions, and update programs with new technology/methods to improve efficiency; meet customer delivery dates
• Coordinate with Quality Engineering to help facilitate the development of Process Control Plans, Manufacturing Inspection Plans, and gaging/fixturing requirements.
• Additional responsibilities as outlined in full job description.

QUALIFICATIONS:

• Bachelor’s degree (mechanical engineering, biomedical engineering, or related) required, with a related advanced degree preferred.
• Minimum of 7 years’ experience within a regulated industry (preferably in a Medical Device or Aerospace Manufacturer).
• Project management experience – plan, development and execution.
• Ability to read drawings and specifications containing GD&T.
• Familiarity with technologies and methods used to define how products are to be manufactured, how to conduct analysis, and meeting quality and compliance standards.
• Extensive experience with transferring multi-disciplinary products from development to production.
• Experience in identifying tooling, along with the appropriate operating conditions (speeds and feeds).
• Additional qualifications as outlined in full job description.

TOMZ Corporation is an Equal Opportunity Employer