Lead Medical Device Systems Engineer

Talentify; Billerica (MA); On-site; USD 120,000 - 155,000; Full time

Job summary

Access Vascular Inc. is seeking a Senior Systems Engineer to lead design control and risk management across the product lifecycle. You will drive V&V testing programs and manage external partners to ensure regulatory compliance and robust device development.

The role requires 7+ years in medical device development, strong leadership, and deep knowledge of ISO 14971, IEC 60601, and related standards. Compensation is commensurate with experience.

Qualifications

• 7+ years in medical device product development with FDA-regulated devices (510(k) or PMA).
• Hands-on experience leading design control and risk management programs.
• Experience managing third-party engineering and manufacturing partners, including supplier qualification and oversight.
• Startup or early-stage company experience — comfortable with ambiguity and wearing multiple hats.

Responsibilities

• Lead the design and development of a medical device with electrical, software, and mechanical features in compliance with QMSR.
• Drive Verification and Validation planning and execution, including IQ/OQ/PQ activities and clinical readiness assessments.
• Provide technical leadership to internal and external engineers, technicians, and consultants.
• Contribute to Risk Management File per ISO 14971, including hazard identification and risk controls across the lifecycle; support regulatory filings (510(k), PMA) and patents.
• Lead system-level design verification and validation activities, including development of V&V plans, protocols, and reports.
• Analyze data for conformance to design specs and implement design improvements.
• Plan and manage testing to IEC, AAMI, and ASTM standards; stay aware of FDA guidance and standards updates.

Skills

Design control

Risk management

V&V testing

Regulatory knowledge

Engineering leadership

ECG knowledge

Requirements management

Firmware development

Education

B.S. in engineering

M.S. preferred

Tools

Jira

DOORS

Jama

Polarion

MS Project

Job description

Access Vascular Inc. is seeking a Senior Systems Engineer to lead design control and risk management across the product lifecycle. You will drive V&V testing programs and manage external partners to ensure regulatory compliance and robust device development.

The role requires 7+ years in medical device development, strong leadership, and deep knowledge of ISO 14971, IEC 60601, and related standards. Compensation is commensurate with experience.