Senior Medical Device Process Engineer: Design Transfer

Accessvascular; Billerica (MA); On-site; USD 110,000 - 145,000; Full time

Job summary

Access Vascular in Billerica, Massachusetts is seeking a Sr. Process Development Engineer to lead design transfer activities from R&D to manufacturing for innovative medical devices. This role entails optimizing manufacturing processes, authoring validation protocols, and ensuring compliance with ISO 13485 and FDA regulations.

The ideal candidate will have over 7 years of relevant experience with a strong understanding of process validation requirements and will actively contribute to ongoing process improvements in a growth-stage start-up environment.

Qualifications

• 7+ years experience in an equipment intensive medical device manufacturing environment.
• 1-2 years of direct supervisory experience is a plus.
• Experience with plastics processing (extrusion, injection molding, fiber forming) is preferred.

Responsibilities

• Lead design transfer activities from R&D to manufacturing.
• Perform process optimization through design of experiments.
• Manage the end-to-end design transfer process.

Skills

Process validation

SolidWorks

Project management

ISO 13485 knowledge

Good Manufacturing Practices

Education

BS in Manufacturing, Mechanical, Industrial or Plastics Engineering

Tools

SolidWorks

Job description

Access Vascular in Billerica, Massachusetts is seeking a Sr. Process Development Engineer to lead design transfer activities from R&D to manufacturing for innovative medical devices. This role entails optimizing manufacturing processes, authoring validation protocols, and ensuring compliance with ISO 13485 and FDA regulations.

The ideal candidate will have over 7 years of relevant experience with a strong understanding of process validation requirements and will actively contribute to ongoing process improvements in a growth-stage start-up environment.