Senior Manufacturing Engineer - Medical Device - Woburn, MA

Are you passionate about making a positive impact on people's lives through cutting-edge medical devices? In this Senior Manufacturing Engineer role you will be responsible for leading manufacturing process development, optimization, and validation activities for medical device products.

Client Details

My client is a global leader in medical device manufacturing, committed to improving healthcare outcomes worldwide. With a focus on innovation, quality, and patient safety, they design and produce cutting-edge medical devices that meet the highest industry standards.

Description

The Senior Manufacturing Engineer will report directly into the Engineering Manager and be responsible for:

• Lead the design, development, and implementation of manufacturing processes for new and existing products.
• Identify opportunities for process improvements and cost reductions, and implement solutions.
• Ensure compliance with all regulatory requirements and industry standards, including ISO 13485 and FDA regulations.
• Conduct root cause analysis and implement corrective actions for manufacturing issues.
• Collaborate with design and R&D teams to ensure manufacturability of new products.
• Develop and maintain process documentation, including work instructions, standard operating procedures (SOPs), and validation protocols.
• Manage and coordinate manufacturing projects, ensuring they are completed on time and within budget.
• Utilize lean manufacturing principles to improve production efficiency and reduce waste.

Apply today for immediate consideration!

Profile

• Bachelors Degree in Biomedical or Mechanical Engineering
• 5-7 years of experience in medical device manufacturing
• Knowledge of regulatory requirements (ISO 13485)
• Lean Manufacturing (Six Sigma Green Belt preferred)
• Proficiency in CAD software (e.g., SolidWorks, AutoCAD)
• Sound analytical and problem-solving skills
• Experience with FEA analysis tools is a plus
• Strong communication skills and ability to work in cross-collaborative teams

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.