Senior Medical Device Systems Engineer

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

Job summary

Accessvascular is seeking a Senior Systems Engineer in Billerica, MA, to lead new product development. This role entails managing design control and risk management processes for medical devices, ensuring compliance with regulatory standards throughout the product lifecycle.

The ideal candidate will have over 7 years of experience in medical device development, leading V&V testing efforts and working closely with teams to facilitate technical and regulatory compliance. Competitive salary and full benefits offered.

Qualifications

• 7+ years’ experience in medical device product development, including FDA regulated devices.
• Demonstrated leadership experience in design control and risk management.
• Proficiency in requirements management and traceability tools.

Responsibilities

• Lead design and development of medical devices with compliance to QMSR.
• Drive V&V planning including test protocol authorship and readiness assessments.
• Provide technical leadership for internal and third-party developers.

Skills

Design control and risk management

Medical device product development

Leadership skills

Technical proficiency in mechanical, electrical, and software systems

Communication skills

Regulatory knowledge

Software skills including Microsoft Office and requirements management tools

Education

B.S. in engineering discipline

M.S. preferred

Tools

DOORS

Jama

Polarion

Microsoft Office (including MS Project)

Jira

Job description

Accessvascular is seeking a Senior Systems Engineer in Billerica, MA, to lead new product development. This role entails managing design control and risk management processes for medical devices, ensuring compliance with regulatory standards throughout the product lifecycle.

The ideal candidate will have over 7 years of experience in medical device development, leading V&V testing efforts and working closely with teams to facilitate technical and regulatory compliance. Competitive salary and full benefits offered.