Best Practices, Continuous Improvement, Documentation, Engineering Drawing, ISO (International Organization for Standardization), Manufacturing, Manufacturing Engineering, Manufacturing/Industrial Processes, Medical Equipment, Procedure Development, Process Validation, Quality Assurance Methodology, Quality Engineering, Regulations, Regulatory Compliance, Regulatory Requirements, Research & Development (R&D), Systems Analysis, Testing, Validation Plan
- We are seeking a skilled Medical Device Manufacturing Engineer to support manufacturing validation, inspection methods, and quality documentation activities within a regulated medical device environment.
- The ideal candidate will have experience developing TMV protocols and reports, creating validation plans, interpreting engineering drawings and specifications, and supporting measurement system analysis activities. Candidates should also possess strong knowledge of inspection tools, ISO compliance, and medical device regulatory documentation.
Roles & Responsibilities:- Write clear TMV (Test Method Validation) protocols and reports.
- Create test procedures, acceptance criteria, and validation plans.
- Interpret test methods, engineering drawings, and product specifications.
- Apply Gage R&R (Repeatability and Reproducibility) methodologies for measurement system analysis.
- Select and utilize appropriate precision measurement tools such as vernier calipers, micrometers, and related inspection instruments.
- Collaborate with Engineering, Quality, Operations, and R&D teams to support manufacturing and validation activities.
- Produce audit-ready documentation in compliance with ISO standards and medical device regulatory requirements.
- Train operators, engineers, and quality personnel on validated inspection methods and best practices.
- Support continuous improvement initiatives related to manufacturing quality and process validation.
Education & Experience:- Bachelor's degree in engineering, Manufacturing, Quality, or related technical field preferred.
- 3+ years of experience in medical device manufacturing, validation, or quality engineering environment.
- Equivalent combination of education and relevant industry experience will also be considered.
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Katalyst Healthcares & Life Sciences