Manufacturing Engineer - Medical Device Industry
Job Description
Job Description
Hiring: Manufacturing Engineer – Medical Device Industry
Location: NJ,USA
Employment Type: Contract
Industry: Medical Devices
Job Summary
We are seeking a skilled Manufacturing Engineer to support the development, validation, and continuous improvement of manufacturing processes for FDA-regulated medical devices. The ideal candidate will have strong experience in GMP environments and a hands-on approach to process optimization, equipment qualification, and cross-functional collaboration.
Key Responsibilities
- Develop, optimize, and validate manufacturing processes for medical devices
- Lead process improvements to enhance efficiency, yield, and product quality
- Support equipment installation, IQ/OQ/PQ, and process validation activities
- Create and maintain manufacturing documentation (SOPs, work instructions, BOMs)
- Collaborate with Quality, R&D, Regulatory, and Supply Chain teams
- Conduct root cause analysis and implement CAPA for manufacturing issues
- Ensure compliance with FDA 21 CFR 820, ISO 13485, and GMP standards
- Support new product introductions (NPI) and design transfer activities
Required Qualifications
- Bachelor’s degree in Mechanical, Manufacturing, Biomedical Engineering, or related field
- 2 years of Manufacturing Engineering experience in the medical device industry
- Strong knowledge of GMP, ISO 13485, and FDA regulations
- Experience with process validation, equipment qualification, and lean manufacturing
- Proficiency in problem-solving tools (FMEA, DOE, SPC, Root Cause Analysis)
Preferred Skills
- Experience with Class II or Class III medical devices
- Six Sigma or Lean certification
- Familiarity with automation, tooling, and fixture design
- Strong communication and documentation skills
Thanks
Suchi
Company DescriptionVastek Inc is managed by a group of dedicated professionals having rich experience of over years in Healthcare, IT consulting and staffing. We are a certified minority owned, Small business company head quartered out of San Diego, with coverage all across United States, Canada, Mexico, Italy and India. We specialize in Engineering, Validation, Regulatory, IT and NON-IT related areas primarily focused on Pharmaceutical / Life Sciences and Medical device companies.
Company Description
Vastek Inc is managed by a group of dedicated professionals having rich experience of over years in Healthcare, IT consulting and staffing. We are a certified minority owned, Small business company head quartered out of San Diego, with coverage all across United States, Canada, Mexico, Italy and India. We specialize in Engineering, Validation, Regulatory, IT and NON-IT related areas primarily focused on Pharmaceutical / Life Sciences and Medical device companies.