Senior Manufacturing Engineer

Senior Manufacturing Engineer

Location: Billerica, MAFinish Line Staffing Services is hiring a Senior Manufacturing Engineer for our client, an innovative medical device company developing and manufacturing advanced single-use medical devices.This is a hands-on engineering position focused on developing, validating, and optimizing manufacturing processes for commercial production and future growth. The Senior Manufacturing Engineer will work cross-functionally to improve manufacturing processes, equipment, tooling, facility layouts, and operational efficiency within a regulated environment.The ideal candidate brings extensive manufacturing or process engineering experience, strong project leadership skills, and a background supporting scalable medical device manufacturing.

Responsibilities

Process Development & Optimization

• Develop, validate, and implement manufacturing processes to support commercial production and future scalability.
• Create and maintain process flow diagrams and value stream maps for current and future products.
• Optimize manufacturing workflows and facility layouts to improve safety, quality, efficiency, and capacity.
• Support manufacturing requirements associated with growth and new product introductions.
• Establish standard work procedures and equipment operating parameters.
• Identify opportunities to improve process capability, consistency, and manufacturing performance.

Documentation & Compliance

• Develop clear and accurate manufacturing documentation, including work instructions, inspection procedures, test protocols, assembly drawings, equipment control documentation, and component drawings.
• Partner with cross-functional teams to identify and resolve technical and quality-related issues.
• Participate in Material Review Board (MRB), customer complaint investigations, CAPA activities, design activities, and regulatory submission support.
• Collaborate with Quality Control to address supplier quality issues and maintain compliance with applicable regulatory requirements.

Tooling, Equipment & Automation

• Collaborate with product development and engineering teams to design and implement manufacturing tooling and fixtures.
• Identify, develop, and deploy automation solutions to improve manufacturing efficiency and scalability.
• Troubleshoot manufacturing equipment and process issues and implement appropriate corrective actions.
• Develop capital equipment proposals based on manufacturing and operational requirements.
• Support the introduction, qualification, and validation of new manufacturing equipment.

Continuous Improvement & Cost Reduction

• Lead continuous improvement initiatives focused on reducing manufacturing costs, improving yield, and minimizing scrap.
• Lead cross-functional efforts to improve production through process enhancements, testing improvements, and product design changes.
• Analyze quality and manufacturing issues and implement corrective and preventive actions.
• Apply data-driven decision-making and Lean manufacturing principles to improve operational performance.

Project & Team Leadership

• Manage engineering projects from concept through implementation, including project plans, timelines, deliverables, and budgets.
• Present project plans, progress, and results to cross-functional teams and key stakeholders.
• Coordinate and delegate project responsibilities based on team expertise and resources.
• Monitor project performance and ensure alignment with short- and long-term organizational objectives.
• Adjust project plans as needed based on technical, operational, and financial considerations.
• Provide mentorship and technical guidance to junior engineers, technicians, and interns.
• Collaborate across functions while maintaining compliance with workplace safety requirements and company procedures.

Qualifications

• Bachelor’s degree in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, Plastics Engineering, or a related discipline.
• Minimum of 8 years of manufacturing or process engineering experience within a regulated manufacturing environment.
• Medical device, medical equipment, or other FDA/ISO-regulated manufacturing experience strongly preferred.
• Demonstrated experience leading the design, development, validation, and implementation of manufacturing processes, fixtures, and tooling.
• Experience with plastic assembly, hardware assembly, electromechanical assembly, and testing processes preferred.
• Proven project management experience with the ability to lead complex, cross-functional initiatives.
• Strong proficiency with SolidWorks, including experience designing manufacturing fixtures and tooling.
• Strong organizational and problem-solving skills with the ability to establish and promote structured engineering workflows.
• Excellent written and verbal communication skills with the ability to collaborate across technical disciplines and organizational levels.
• Ability to manage multiple priorities and adapt to changing requirements in a fast-paced manufacturing environment.
• Six Sigma Green Belt or Black Belt certification preferred.
• Experience with plastics processing techniques, including extrusion, injection molding, and fiber forming, preferred.

Finish Line Staffing Services is recruiting for this opportunity on behalf of our client. Qualified candidates with strong manufacturing engineering experience in regulated environments are encouraged to apply.