More jobs:
Manufacturing Engineer
Job in
Danvers, Essex County, Massachusetts, 01923, USA
Listed on 2026-06-02
Listing for:
Katalyst Healthcares & Life Sciences
Full Time
position Listed on 2026-06-02
Job specializations:
-
Engineering
Quality Engineering, Biomedical Engineer -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
- 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.
- 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.
- 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.
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×