Senior Manufacturing Engineer

Position Summary

The Senior Manufacturing Engineer will play a critical, hands-on role in developing, validating, and optimizing manufacturing processes for next-generation, single-use medical devices made from novel biomaterials. This is a unique opportunity to join an early-stage, innovation-driven organization with significant potential for career advancement.

The ideal candidate brings deep expertise in process development, project leadership, and scalable manufacturing, and thrives in a fast-paced environment focused on continuous improvement across processes, facilities, and equipment.

Essential Duties & Responsibilities

• Process Development & Optimization
• Develop, validate, and implement manufacturing processes in support of commercial production and future scale-up.
• Create and maintain process flow diagrams and value stream maps for existing and new products.
• Optimize process flow and facility layout to enhance safety, quality, efficiency, and capacity for growth and new product introductions.
• Establish standard work procedures, process parameters, and best-practice operating methods.
• Documentation & Compliance
• Author clear and comprehensive work instructions and process documentation, including inspection procedures, test protocols, assembly drawings, and equipment controls.
• Work cross-functionally to resolve technical and quality issues, including participation in MRB, complaint investigations, CAPA activities, design projects, and regulatory submissions.
• Partner with Quality Control to address supplier-related issues and maintain compliance with applicable regulatory standards.
• Tooling, Equipment & Automation
• Collaborate with product development teams to design and implement manufacturing tooling, fixtures, and related systems.
• Identify, develop, and deploy automation solutions to improve throughput and reduce variability.
• Troubleshoot equipment and process issues to implement corrective actions.
• Prepare capital equipment proposals to support evolving manufacturing needs.
• Continuous Improvement & Cost Reduction
• Lead continuous improvement initiatives aimed at reducing cost, improving yield, and minimizing scrap.
• Drive cross-functional efforts to streamline production through process improvements, test optimization, and product design updates.
• Analyze quality issues and implement data-driven corrective and preventive actions.
• Promote operational excellence using lean manufacturing and structured problem-solving methods.
• Project & Team Leadership
• Manage engineering projects from concept through execution, including developing detailed project plans and timelines.
• Provide regular project updates and communicate progress to cross-functional teams and stakeholders.
• Delegate tasks effectively based on team strengths and project requirements.
• Monitor project performance and ensure alignment with organizational objectives and budget constraints.
• Support team operations by adhering to safety protocols and assisting colleagues as needed.
• Mentor and train junior engineers, technicians, and interns.

Skills & Qualifications

• Bachelor’s degree in Manufacturing, Mechanical, Industrial, or Plastics Engineering.
• Minimum of 8 years of manufacturing or process engineering experience in a regulated environment; FDA/ISO-regulated medical device experience strongly preferred.
• Demonstrated experience designing, developing, and validating manufacturing processes, fixtures, and tooling.
• Preferred experience with plastic assembly, hardware assembly, electromechanical assembly, and related test processes.
• Proven project management skills with the ability to lead cross-functional initiatives.
• Proficiency in SolidWorks, including fixture and tooling design.
• Strong organizational skills and ability to establish structured workflows within engineering teams.
• Excellent written and verbal communication skills with the ability to engage effectively across all organizational levels.
• Demonstrated adaptability in managing multiple priorities in a fast-paced, dynamic environment.
• Six Sigma Green Belt or Black Belt certification (preferred).
• Experience with plastics processing techniques (e.g., extrusion, injection molding, fiber forming) is a plus