Senior Manufacturing Engineer, Med Device Process Innovator

Accessvascular; Billerica (MA); On-site; USD 115,000 - 145,000; Full time

Job summary

Access Vascular is seeking a Senior Manufacturing Engineer to develop and optimize manufacturing processes for next-generation, single-use medical devices. You will lead process development, validation, and automation efforts in a fast-paced, regulated environment, focusing on quality, efficiency, and scalability.

The role requires a strong background in process development, project management, and lean principles, with experience in plastics processing and design-for-manufacturing.

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.
• Proficiency in SolidWorks, including fixtures and tooling design.
• Six Sigma Green Belt or Black Belt preferred.
• Experience with plastics processing techniques such as extrusion, injection molding and fiber forming preferred.

Responsibilities

• Develop, validate, and implement manufacturing processes for commercial production and scalability.
• Create and maintain process flow diagrams and value stream maps for current and future products.
• Optimize process flow and facility layout to improve safety, quality, efficiency and accommodate growth.
• Write clear work instructions and process documentation supporting medical device manufacturing.
• Lead continuous improvement initiatives to reduce costs, improve yield, and minimize scrap.
• Manage engineering projects from concept through execution with plans, timelines, and budgets.

Skills

Project management

Communication

Lean manufacturing

Adaptability

Education

Bachelor's degree in Manufacturing, Mechanical, Industrial, or Plastics Engineering

Tools

SolidWorks

Job description

Access Vascular is seeking a Senior Manufacturing Engineer to develop and optimize manufacturing processes for next-generation, single-use medical devices. You will lead process development, validation, and automation efforts in a fast-paced, regulated environment, focusing on quality, efficiency, and scalability.

The role requires a strong background in process development, project management, and lean principles, with experience in plastics processing and design-for-manufacturing.