Job Application: Principal Manufacturing Engineer

Title: Principal Manufacturing Engineer

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TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a motivated Principal Manufacturing 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.


Reporting to the Director of Engineering, 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.


  • This position may have direct-reporting responsibilities for daily activities of site Engineering personnel (responsibility dependent on geographic organizational structure).
  • Develop manufacturing processes, procedures and production layouts for assemblies, , processing, machining and material handling.
  • Develop and perform installation, operational and process qualifications for customer manufacturing processes in cooperation with cross-functional engineering teams per project requirements.
  • Layout of machines within the manufacturing space to ensure most efficient and productive manufacturing flow.
  • Develops sequence of operations and specifies procedures for the manufacturing of product.
  • Adapts machine or equipment design to facility and production conditions.
  • May incorporate inspection and test requirements into the production plan.
  • Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
  • Develops manufacturing processes that are applicable to statistical process control and may develop those techniques.
  • Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
  • Identify and support business growth opportunities and present recommendations to management.
  • May be required to act as lead technical problem solver within area of specialization.
  • Develop and deliver presentations to communicate status, problem resolution or promote related business products.
  • Ensures processes and procedures are in compliance with regulations.
  • Other duties as assigned.


  • 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).
  • Strong record of manufacturing knowledge, with both hands-on and management experience, including the following:
  • 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.
  • Possess a high attention to detail.
  • Proficiency in SolidWorks
  • Proficient in the use of Microsoft Office, and Adobe products.
  • Solid knowledge of GMP and ISO 13485 regulations
  • Experience associated with continuous improvement activities, including participations and/or facilitating Kaizen events using lean manufacturing principles.
  • Ability to work in a fast-paced Medical Device Manufacturing environment with high output efficiency and impeccable quality standards.
  • Exhibit good time management skills and ability to prioritize work load.
  • Motivated self-starter with ability to work both independently and as part of a team.
  • Good communication skills with superiors, peers, and subordinates.
  • Strong verbal and written English language communication skills.

Physical Demands

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is frequently required to stand, and/or walk. The employee must occasionally lift and/or move up to 30 pounds while moving components, fixtures, equipment and/or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

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