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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. Process and Development 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 13485.
SUMMARY OF POSITION:
Reporting to the Department Manager, this position is primarily responsible for working in a functional project engineering group, consisting of multiple engineering disciplines. Involved in development, documentation and validation of new customer products, and the modification of existing production products. Including timelines and deliverables with a focus on process development, training production personnel and preparation for process validation and manufacturing transfer of products.
- Lead PE representative on project. Provide input on resources needed and project planning.
- Attends and arranges project meetings to discuss current and future development initiatives.
- May serve as a primary contact with customers on projects of moderate complexity.
- Assists with preparation of proposals and quotations; interface as needed to resolve questions in a timely manner.
- Assist in preparation and maintaining of project plans to satisfy milestones, deadlines, and budgets. Track and communicate project status, plans, issues, timelines, action items, and budgets.
- Provide guidance and direction to coworkers on areas of technical expertise.
- Troubleshoot production processes as required.
- Responsible for the following project inputs:
- Equipment selection
- Process development and documentation
- Operator training
- Process Validation
- Manufacturing transfer and support of existing product lines as applicable
- Other duties as assigned.
- A Bachelors’ degree in an engineering discipline with 5 years of relevant experience; Associates degree in an engineering discipline with a minimum of 10 years relevant work experience; or equivalent.
- Experience in a regulated engineering/manufacturing environment with mechanical, tool design, and manufacturing processes preferred. industry (preferably in a Medical Device or Aerospace Manufacturer)
- Excellent verbal and written communication skills
- Willingness to travel, if required.
- Must maintain high ethical standards.
- Must demonstrate good organizational skills.
- Ability to train new engineering employees on project engineering activities and TOMZ policies and procedures.
- Experience in an engineering/manufacturing environment with mechanical, tool design, and manufacturing processes preferred.
- Strong computer skills, including the MS Office suite and MS Project.
- Must be able to fully interpret technical drawings, blueprints, specifications & illustrations.
- Strong analytical skills, must be able to obtain, evaluate, and apply secondary research information.
- Ability to learn and apply new technology.
- Technical report preparation and formal presentation 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.