FUSTIS LLC
Senior Manufacturing Engineer – Medical Device
FUSTIS LLC, Burlington, Massachusetts, us, 01805
Senior Manufacturing Engineer – Medical Device
This range is provided by FUSTIS LLC. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $130,000.00/yr - $130,000.00/yr
Position:
Senior Manufacturing Engineer – 7+ years of medical device experience
Location:
Burlington, MA area
Duration:
Full-Time/Direct (W2)
Domain:
Medical Device
Interview:
Teams Meetings (2) – then potential onsite interview (client pays)
Salary:
$130K, 10% bonus
VISA:
US, Green Card, no GC_EAD
Industries/Domains to target
Medical Device
Job Description Senior Manufacturing Engineer – Medical Device (Hands-On Role)
We’re seeking a hands-on Senior Manufacturing Engineer to support daily production and process improvement for medical devices, ensuring compliance with FDA and ISO 13485 standards.
Responsibilities
Develop, validate, and improve manufacturing processes and equipment (IQ/OQ/PQ).
Work directly on the production floor to troubleshoot and resolve process and quality issues.
Lead root cause investigations and implement corrective/preventive actions.
Partner with Quality, R&D, and Operations to support design transfer and new product builds.
Maintain accurate documentation, including DHRs, BOMs, and process instructions.
Qualifications
Bachelor’s degree in Engineering and 7+ years of medical device manufacturing experience.
Strong understanding of GMP, FDA 21 CFR 820, and ISO 13485 requirements.
Proven ability to work cross-functionally and solve complex process problems.
Hands-on NPI (New Product Introduction) experience is a major plus.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Information Technology
Industries
Staffing and Recruiting
Referrals increase your chances of interviewing at FUSTIS LLC by 2x
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Base pay range $130,000.00/yr - $130,000.00/yr
Position:
Senior Manufacturing Engineer – 7+ years of medical device experience
Location:
Burlington, MA area
Duration:
Full-Time/Direct (W2)
Domain:
Medical Device
Interview:
Teams Meetings (2) – then potential onsite interview (client pays)
Salary:
$130K, 10% bonus
VISA:
US, Green Card, no GC_EAD
Industries/Domains to target
Medical Device
Job Description Senior Manufacturing Engineer – Medical Device (Hands-On Role)
We’re seeking a hands-on Senior Manufacturing Engineer to support daily production and process improvement for medical devices, ensuring compliance with FDA and ISO 13485 standards.
Responsibilities
Develop, validate, and improve manufacturing processes and equipment (IQ/OQ/PQ).
Work directly on the production floor to troubleshoot and resolve process and quality issues.
Lead root cause investigations and implement corrective/preventive actions.
Partner with Quality, R&D, and Operations to support design transfer and new product builds.
Maintain accurate documentation, including DHRs, BOMs, and process instructions.
Qualifications
Bachelor’s degree in Engineering and 7+ years of medical device manufacturing experience.
Strong understanding of GMP, FDA 21 CFR 820, and ISO 13485 requirements.
Proven ability to work cross-functionally and solve complex process problems.
Hands-on NPI (New Product Introduction) experience is a major plus.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Information Technology
Industries
Staffing and Recruiting
Referrals increase your chances of interviewing at FUSTIS LLC by 2x
#J-18808-Ljbffr