Title: Sr. Process and Development Engineer
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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, 401K 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; interfaces as needed to resolve questions in a timely manner.
- Assists in the preparation and maintaining of project plans to satisfy milestones, deadlines, and budgets.
- Tracks, communicates project status, project plans and issues, timelines, action items and budgets.
- Provides guidance and direction to coworkers on areas of technical expertise.
- Ability to 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. (Preferably in a Medical Device or Aerospace Manufacturing Environment)
- 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 policies and procedures.
- Experience in an engineering/manufacturing environment with mechanical, tool design, and manufacturing processes preferred.
- Strong computer skills, including MS Office suite and MS Project.
- Must be able to fully interpret technical drawings, blueprints, specifications & illustrations.
- Strong analytical skills and the ability 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.