Senior Medical Device Systems Engineer V&V Design Controls

Access Vascular, Inc.; Billerica (MA); On-site; USD 120,000 - 155,000; Full time

Job summary

Access Vascular, Inc. is seeking a Senior Systems Engineer to lead new product development with emphasis on design control and risk management across the product lifecycle.

You will manage V&V testing programs and coordinate external partners while ensuring compliance with regulatory standards and quality systems. The role requires hands-on leadership in medical device development, coordinating cross-functional teams to meet technical, regulatory, and business objectives, and contributing to

Qualifications

• Bachelor's degree in engineering; MS preferred.
• 7+ years in medical device product development with FDA-regulated devices.
• Experience leading design control and risk management programs.
• Experience managing third-party engineering and manufacturing partners.

Responsibilities

• Lead design and development of a medical device with electrical, software, and mechanical components.
• Drive V&V planning and execution including IQ/OQ/PQ and clinical readiness assessments.
• Provide technical leadership to internal and external engineers and consultants.
• Contribute to Risk Management File per ISO 14971 and regulatory filings (510(k), PMA).
• Lead system-level design verification and validation activities and test method validation.
• Identify design improvements and ensure standards compliance and regulatory testing.

Skills

Systems engineering

Regulatory knowledge

V&V testing

Project leadership

ECG knowledge

Communication

Embedded software

Third-party management

Education

B.S. in engineering

M.S. preferred

Tools

Jira

DOORS

Jama

Polarion

MS Project

Python

Embedded C/C++

Job description

Access Vascular, Inc. is seeking a Senior Systems Engineer to lead new product development with emphasis on design control and risk management across the product lifecycle.

You will manage V&V testing programs and coordinate external partners while ensuring compliance with regulatory standards and quality systems. The role requires hands-on leadership in medical device development, coordinating cross-functional teams to meet technical, regulatory, and business objectives, and contributing to