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.
- 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.
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.