Senior Manufacturing Engineer: MedTech Process & Scale Lead

Access Vascular, Inc.; Billerica (MA); On-site; USD 115,000 - 145,000; Full time

Job summary

Access Vascular, Inc. is seeking a Senior Manufacturing Engineer to develop and optimize manufacturing processes for single-use medical devices made from novel biomaterials. The role focuses on process development, continuous improvement, and scalable production in a fast-paced environment.

You will lead process documentation, cross-functional collaborations, and automation initiatives to support commercial production and future growth. Compensation ranges with experience and market norms.

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).
• Experience leading design, development, and validation of production processes, fixtures, and tooling.

Responsibilities

• Drive process excellence for commercial production and future scalability.
• Create and maintain process flow diagrams and value stream maps.
• Optimize process flow and facility layout for safety, quality, efficiency and growth.
• Establish standard work procedures and equipment operating parameters.
• Write and maintain work instructions and process documentation.
• Collaborate with cross functional teams on issues including CAPA and regulatory submissions.
• Develop and deploy automation solutions to improve efficiency.
• Lead continuous improvement initiatives to reduce costs and scrap.
• Manage projects from concept to execution with plans, timelines, and budgets.
• Mentor and train junior engineers, technicians, and interns.

Skills

Project management

Organizational skills

Communication

Lean manufacturing

Data-driven decision making

Mentorship

Education

Bachelor’s degree in Manufacturing/Mechanical/Industrial/Plastics Engineering

Tools

SolidWorks

Job description

Access Vascular, Inc. is seeking a Senior Manufacturing Engineer to develop and optimize manufacturing processes for single-use medical devices made from novel biomaterials. The role focuses on process development, continuous improvement, and scalable production in a fast-paced environment.

You will lead process documentation, cross-functional collaborations, and automation initiatives to support commercial production and future growth. Compensation ranges with experience and market norms.