Senior Process Development Engineer - Design Transfer Lead

Access Vascular, Inc.; Billerica (MA); On-site; USD 110,000 - 145,000; Full time

Job summary

Access Vascular, a growth-stage medical device company, seeks a Sr. Process Development Engineer to lead design transfer from R&D to manufacturing, develop IQ/OQ/PQ protocols, and guide process validation under QMSR and ISO 13485.

You will drive process optimization, develop automation, mentor staff, and ensure GMP/SOP compliance while collaborating with Quality, Regulatory and Operations to deliver transfer-ready processes.

Qualifications

• 7+ years in an equipment-intensive medical device manufacturing environment.
• 1-2 years of direct supervisory experience is a plus.
• Project management experience is preferred.
• Proficient with SolidWorks; ability to design, prototype, and evaluate fixtures and tooling.
• Experience with plastics processing (extrusion, injection molding, fiber forming).
• Solid understanding of ISO 13485, FDA QMSR, and design transfer requirements; experience writing IQ/OQ/PQ protocols.
• Demonstrated ability to stay organized and implement organizational skills.
• Strong verbal and written communication skills.
• Ability to respond to changing priorities and multitask in a dynamic environment.

Responsibilities

• Lead design transfer activities from R&D to manufacturing, including IQ, OQ, PQ protocols per FDA QMSR and ISO 13485.
• Perform process optimization through DoE and process capability studies.
• Engage early in design cycle providing manufacturability input to reduce transfer risk.
• Establish standard work and equipment operating parameters.
• Author and maintain design transfer and process validation documentation.
• Lead and guide technicians and junior engineers on transfers.
• Develop and implement automation solutions.
• Troubleshoot equipment problems and implement corrective actions.
• Analyze quality problems and implement improvements.
• Ensure validated, transfer-ready processes with traceability to design inputs.
• Work with Quality to resolve supplier quality issues.
• Coordinate end-to-end transfer with R&D, Quality, Regulatory, and Operations.
• Enforce GMP and SOP compliance.

Skills

Leadership

Project management

Design for manufacturability

Cross-functional collaboration

Communication skills

Education

BS in Manufacturing, Mechanical, Industrial or Plastics Engineering

Tools

SolidWorks

Job description

Access Vascular, a growth-stage medical device company, seeks a Sr. Process Development Engineer to lead design transfer from R&D to manufacturing, develop IQ/OQ/PQ protocols, and guide process validation under QMSR and ISO 13485.

You will drive process optimization, develop automation, mentor staff, and ensure GMP/SOP compliance while collaborating with Quality, Regulatory and Operations to deliver transfer-ready processes.