Senior Manufacturing Engineer - Medical Device - Lowell, MA

As a Senior Manufacturing Engineer you will be taking on a variety of roles to meet the needs of an evolving product and company. You will be responsible for driving excellence in production processes, ensuring the delivery of high-quality, life-saving medical devices.

Client Details

My client is a Medical Equipment manufacturer, committed to delivering safe, high-quality, and effective products that improve lives. They pride themselves on their dedication to excellence, innovation, and compliance in all stages of manufacturing.

Description

The Senior Manufacturing Engineer will report directly into the VP of Operations and be responsible for:

• Lead the design, optimization, and validation of manufacturing processes for advanced medical devices.
• Collaborate with R&D, quality, and regulatory teams to ensure compliance with medical device standards (e.g., ISO 13485, FDA regulations).
• Develop and implement lean manufacturing strategies to enhance efficiency and reduce costs.
• Drive process improvements using statistical analysis, Six Sigma methodologies, and other best practices.
• Oversee the scale-up of production for new products, ensuring seamless transition from prototype to full-scale manufacturing.
• Troubleshoot technical issues in manufacturing and implement corrective and preventive actions (CAPA).
• Write and execute process validations (IQ/OQ/PQ) and PFMEAs.
• Mentor junior engineers and support cross-functional teams in achieving operational goals.

Apply today for immediate consideration!

Profile

• Bachelors Degree in Mechanical Engineering or a related field
• 5+ years of experience in manufacturing engineering, preferably in the medical device or healthcare industry.
• Expertise in process validation (IQ, OQ, PQ) and Design for Manufacturability (DFM).
• Strong knowledge of regulatory standards (e.g., FDA, ISO 13485) and quality systems.
• Proficiency in CAD software and manufacturing tools (e.g., FMEA, SPC, Minitab).
• Proven track record of leading cross-functional projects and implementing process improvements.
• Excellent problem-solving skills and a proactive approach to challenges.

Job Offer

• Competitive compensation
• Comprehensive benefits plan
• Career growth opportunities
• Access to high level management
• 401K match
• Excellent work life balance

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.