Summary

The Senior Manufacturing Engineer will play a pivotal, hands-on role in developing and optimizing manufacturing processes for cutting-edge, single-use medical devices made from novel biomaterials. This position offers a unique opportunity to contribute to an early-stage, innovation-driven company with strong potential for career growth. The ideal candidate brings deep expertise in process development, project management, and scalable manufacturing, and thrives in a fast-paced environment focused on continuous improvement across processes, facilities, and equipment.

Essential Duties and Responsibilities

As a key member of the manufacturing engineering team, you will be responsible for driving process excellence, supporting commercial production, and enabling future scalability of medical device manufacturing operations. Your core responsibilities will include:

Process Development & Optimization

• Work hands-on to 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 process flow and facility layout to improve safety, quality, efficiency, and accommodate growth and new product introductions.
• Establish standard work procedures and equipment operating parameters.

Documentation & Compliance

• Write clear, concise work instructions and process documentation to support commercial medical device manufacturing, (including inspection procedures, test protocols, assembly drawings, equipment control documentation, and component drawings).
• Work with cross functional teams to identify and resolve technical and quality related issues including participation in MRB, customer complaint investigations, CAPA related activities, design activities, and regulatory submissions.
• Collaborate with Quality Control to resolve supplier quality issues and ensure compliance with regulatory standards.

Tooling, Equipment & Automation

• Collaborate with product development teams to design and implement manufacturing tooling and fixtures.
• Identify, develop, and deploy automation solutions to improve process efficiency.
• Troubleshoot equipment issues and implement corrective actions.
• Develop capital equipment proposals to support manufacturing needs.

Continuous Improvement & Cost Reduction

• Lead continuous improvement initiatives to reduce manufacturing costs, improve yield, and minimize scrap.
• Lead cross-functional efforts to streamline production through process improvements, test improvements, and product design changes.
• Analyze quality issues and implement corrective and preventive actions.
• Drive operational excellence through data-driven decision-making and lean manufacturing principles.

Project & Team Leadership

• Manage engineering projects from concept through execution, including developing comprehensive project plans and timelines.
• Present project updates and plans to cross-functional teams and stakeholders.
• Delegate tasks effectively based on team members’ strengths and experience.
• Monitor project performance and ensure alignment with short- and long-term organizational goals.
• Manage project budgets and adjust plans based on financial analysis.
• Serve as strong team player, supporting and assisting supervisor and colleagues when necessary and complying with all work safety rules and regulations.
• Provide mentorship and training to junior engineers, technicians, and interns.

Skills and Qualifications

• Bachelor’s degree in Manufacturing, Mechanical, Industrial, or Plastics Engineering.
• Minimum of 8 years of manufacturing or process engineering experience in a regulated manufacturing environment, preferably FDA/ISO regulated medical device or medical equipment manufacturing.
• Prior experience leading the design, development, and validation of production processes, fixtures, and tooling.
• Prior work experience leading the development of plastic assembly, hardware assembly, electromechanical assembly and test processes is preferred.
• Proven project management experience, with the ability to lead cross-functional initiatives.
• Proficiency in SolidWorks, including demonstrated expertise in designing fixtures and tooling.
• Strong organizational skills with the ability to implement and promote structured workflows within engineering teams.
• Excellent verbal and written communication skills; capable of effectively communicating across all levels and disciplines of the organization.
• Adaptability to shifting priorities and ability to manage multiple tasks in a fast-paced, dynamic environment.
• Six Sigma Green Belt or Black Belt (preferred).
• Experience with plastics processing techniques such as extrusion, injection molding, and fiber forming (preferred)