Senior Manufacturing Engineer - Medical Device - Lowell, MA

The Senior Manufacturing Engineer will join a small team reporting directly into the Vice President. This person will wear several hats, with responsibilities including supplier management, hands-on assembly, cleanroom operations, NPI efforts, test and process validations, and sterilizations.

Client Details

My client is a medical device manufacturer specializing in the development of innovative implantable and cardiovascular devices. Based in the Lowell, Massachusetts area, they focus on manufacturing devices that address a condition that affects millions of people worldwide and has limited treatment options. In this position you would work on a small team that makes a large impact!

Description

The main responsibilities for the Senior Manufacturing Engineer include, but are not limited to:

• Oversee product manufacturing in a cleanroom environment and support ongoing production activities.
• Provide engineering expertise for the manufacturing of devices.
• Design and refine manufacturing processes for new products, ensuring alignment with design-for-manufacturing principles.
• Lead the design and development of manufacturing fixtures and equipment for both early-stage and production use.
• Oversee early production builds, including feasibility, design verification (DV), and process validation stages, for products in development.
• Train production teams and implement new manufacturing processes effectively.
• Author and execute process validations (IQ, OQ, PQ) and conduct PFMEA analyses.
• Identify and establish relationships with contract manufacturers and suppliers for early-stage production, and collaborate on scaling operations to full production.
• Manage product logistics to ensure timely delivery and support of field supply needs.

Profile

The successful Senior Manufacturing Engineer will have the following qualifications:

• Bachelor's degree or higher in an Engineering discipline (e.g., Mechanical, Manufacturing, Biomedical) or a related field.
• 5+ years of work experience in the medical device industry.
• Proven experience in manufacturing disposable medical devices, catheters, or implants is highly preferred.
• Familiarity with EO (ethylene oxide) sterilization processes.
• Experience with 3D CAD software, such as SolidWorks.
• Experience with 3D printing technologies is a plus.
• Hands-on experience in a machine shop environment.
• Background in LEAN manufacturing principles and methodologies.

Apply today for immediate consideration!

Job Offer

• Competitive compensation
• Comprehensive benefits package
• 401K with company match
• Full health insurance including medical, dental and vision
• Generous PTO
• 11 paid holidays
• Great company culture

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.