Senior Systems Verification Lead – Medical Devices (Hybrid)

Olympus Corporation; Massachusetts; Híbrido; USD 138.000 - 193.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive salary

Annual bonus

401(k) with company match

On-site facilities

Descripción de la vacante

Olympus Corporation, Westborough, MA, invites a seasoned System Verification leader to drive design, development and execution of verification and validation plans ensuring our medical devices meet user and system requirements and regulatory standards.

You will lead cross-functional teams, manage test protocols and reports, maintain ISO and GMP documentation, and uphold our commitment to patient safety. Travel is minimal; a strong problem-solving mindset and communication skills are essential.

Formación

• B.S. or M.S. in Computer Science, Mechanical or Electrical Engineering or related field.
• Minimum 14 years in System Verification of complex software/hardware systems.
• Minimum 10 years with MS in System Verification of complex software/hardware systems.
• Minimum 8 years with Ph.D. in System Verification of complex software/hardware systems.
• Minimum 5 years of System Verification under Medical Device Regulations.
• Experience with systems verification and user validation.
• Travel requirement: Less than 10%.

Responsabilidades

• Lead, develop and execute system verification test plans and compile results.
• Participate in cross-functional design reviews, hazard analysis and risk assessments.
• Perform root cause analysis and propose process improvements.
• Communicate findings and recommendations within and outside the team.
• Use Defect Tracking System to report and resolve software issues.
• Maintain documents per ISO and GMP guidelines and Olympus processes.
• Ensure compliance with regulatory standards (FDA QSR, ISO 13845, EU MDR).
• Follow environmental, health and safety site rules.
• All other duties as assigned.

Conocimientos

System Verification

Analytical skills

Communication

Leadership

Educación

B.S./M.S. in Computer Science or Engineering

Herramientas

Defect Tracking System

Descripción del empleo

Olympus Corporation, Westborough, MA, invites a seasoned System Verification leader to drive design, development and execution of verification and validation plans ensuring our medical devices meet user and system requirements and regulatory standards.

You will lead cross-functional teams, manage test protocols and reports, maintain ISO and GMP documentation, and uphold our commitment to patient safety. Travel is minimal; a strong problem-solving mindset and communication skills are essential.