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TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a motivated 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 Department Manager, this position will have direct responsibility for developing and implementing robust cost-effective manufacturing processes and methods, recommending improvements to sustained production processes, methods, and controls, as well as coordinating the launch of new products into production. TOMZ manufactures parts via high precision metal machining, finishing, assembly, and anodize processes for Medical Devices.
- Maintain Manufacturing Process Plans, ERP Masters/ BOM
- Participate in identification and planning of department goals with implementation of initiatives intended to improve quality, cost, and delivery.
- Support Production in reducing / eliminating equipment and tooling downtime or scrap.
- Lead and/or facilitate A3 projects and teams.
- Support Programmers in fixture design for manufacturing process and quality inspection departments.
- Conduct Process Capability studies during manufacturing processes to support achieving objectives.
- Collaborate with cross-functional teams during development phase(s) and provide inputs and recommendations for design for manufacturability (DFM).
- Improve manufacturing processes, methods and controls for cost reduction while providing quality improvements and efficiency for both sustained and new products.
- Prepare engineering change orders and coordinate the deployment of changes, including training operation team members.
- Improve manufacturing process instructions, product flow, assembly methods, space allocation, product quality and safety performance for both sustained and new products.
- Assist in the manufacturing launch of new products including establishing yield targets, run rates, training needs, and evaluating results.
- Assist in the development and qualification of various tools and equipment required for manufacturing processes.
- Support required equipment qualification and process validations (IQ, OQ and PQ).
- Troubleshoot manufacturing processes when defects occur. Support investigations to determine root cause and implement effective containment and countermeasures.
- Redevelop non-conforming products and develop re-work procedures.
- Communicate with customers regarding process improvements and production changes.
- Represent manufacturing on cross functional teams.
- Hands-on Value Stream Mapping (VSM) experience is a must.
- Supports Kaizen events and drives continuous improvement efforts.
- Perform other duties as assigned.
- Minimum of a bachelor’s degree in an engineering discipline or equivalent experience.
- Minimum of 3 years' experience within a regulated high-volume manufacturing industry (preferably in a Medical Device or Aerospace Manufacturer).
- Must possess a high attention to detail
- Ability to read drawings and specifications containing GD&T
- 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 workflow throughout the day.
- Experience utilizing ERP systems; Epicor preferred.
- Motivated self-starter with ability to work both independently and as part of a team.
- 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.