SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES:
- Execute product testing to support:
- Manufacturing development
- Develop test methods for product evaluation and validation. Develop and execute test method validations.
- Develop and execute required validations in line with regulatory requirements to include Equipment, Process and Product validations.
- Address design and tolerance issues as they arise.
- Design and development of test fixtures and simulated use models.
- Analysis and reporting of results including statistics and image analysis
- Authorship of test methods, protocols & reports.
- Coordination with Manufacturing, Operations, and external suppliers as needed.
Other duties as assigned
1-3 years’ experience in industry under a quality system (ISO 9000/9001, ISO 13485, etc.)
- Experience in laboratory work and hands-on testing
- Analytical approach to problem solving
- Adept at managing multiple tasks, prioritizing and working with others
- Ability to analyze, understand and effectively communicate technical information
- Working knowledge of basic statistics
- Experience in medical devices a plus
B.S. or B.E. in the field of Mechanical Engineering, Biomedical Engineering, Physics or related.
Job Type: Full-time
Pay: From $70,000.00 per year
Ability to commute/relocate:
- Sudbury, MA: Reliably commute or planning to relocate before starting work (Preferred)
Work Location: One location