Job Function Summary:
Supports the production department by coordinating engineering functions for medical devices.
Job Functions: (Primary “essential” duties and responsibilities)
- Modify and improve existing equipment. Improve manufacturing efficiency, production yields, product quality and consistency through equipment and product design modifications and fabrication.
- Finalizes manufacturing methods for medical devices.
- Responsible for process validation.
- Provide assistance for equipment design for producing medical devices and components.
- Responsible for processing ECO's.
- Supports production and manufacturing.
- Analyzes and documents test results for development and pilot production runs.
- Responsible for tooling maintenance and upgrades.
- Responsible for manufacturing methods and their transfer into production.
Job Functions (continued): (Primary “essential” duties and responsibilities)
- Engineering support which includes; vendor contact and auditing specification.
- Develops and tests components and assemblies of manufacturer's products.
- Assists in special projects as needed.
- Contributes to team effort by accomplishing related duties as requested.
Required Knowledge, Skills and Abilities: Soft skills and technical requirements to be listed here.
- Demonstrated analytical and problem solving skills.
- Experience in new product development, introduction processes and procurement protocols.
- Effective communication skills both verbal and written.
- Ability to function as part of a team, and accomplish assigned tasks independently.
- The ability to be flexible while maintaining a positive attitude.
Minimum Requirements: minimum requirements for the position.
- Bachelors or Masters' Degree in Engineering, or equivalent.
- A minimum of five years related manufacturing experience.
- Good computer skills, including MS Office applications (Word/Excel) are required.
Quality Requirements (Required language- Please do not edit):
- Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
- Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
- Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
- Attend all required Quality & Compliance training at the specified interval.
- Adopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed requirements.
Environmental/Safety/Physical Work Conditions:
- Ensures environmental consciousness and safe practices are exhibited in decisions.
- Duties are performed in an office/manufacturing environment. Personal protective equipment may be required as dictated by work environment.
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