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TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a motivated Sr. 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 Operations Manager, this position will have direct responsibility for developing and implementing robust cost-effective manufacturing processes and methods, recommends improvements to sustained production processes, methods, and controls, 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.
- Maintain Manufacturing Process Plans, ERP Masters / BOM.
- Support production in reducing / eliminating equipment and tooling downtime or scrap.
- Support programmers in fixture design for manufacturing process and quality inspection departments.
- Conduct Process Capability studies during manufacturing processes to support achieving objectives.
- Collaborates with cross-functional teams during development phase(s) and provides inputs and recommendations for design for manufacturability (DFM).
- Improves manufacturing processes, methods and controls for cost reduction, quality improvements and efficiency for both sustained and new products.
- Prepares engineering change orders and coordinates 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.
- Coordinates the manufacturing launch of new products including establishing yield targets, run rates, training needs and evaluating results.
- Develop and qualify various tools and equipment required for manufacturing processes.
- Performs product and process analysis for cost reduction, quality improvement and improved efficiency.
- Utilizing tools associated with risk management (e.g. PFMEA) to identify potential risks and the associated corrective actions.
- Supporting required equipment qualification and process validations (IQ, OQ and PQ).
- Troubleshoot manufacturing processes when defects occur. Leads investigations to determine root cause and implement effective containment and countermeasures.
- Disposition non-conforming products and develop re-work procedures.
- Communicate with customers regarding process improvements and production changes.
- Represent manufacturing on cross-functional teams.
- Leads Kaizen events and drives continuous improvement efforts.
- Performs other duties as assigned.
Minimum of a bachelor’s degree in an engineering discipline or equivalent experience.
- Minimum of 5 years’ experience within a regulated 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 work flow throughout the day.
- 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.