Job Application: Principal Manufacturing Engineer

Title: Principal Manufacturing Engineer

Fields marked with an asterisk (*) must be filled out before submitting.

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.

SUMMARY OF POSITION:

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.

ESSENTIAL FUNCTIONS:

  • 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.

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).
  • 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.

Personal information


Education history


Did you graduate?
Did you graduate?
Did you graduate?
+ Add more education
Did you graduate?

Employment history


to
+ Add more history
to

What position are you applying for?


General information


Confirm

DOCUMENTS AND SUBMIT