Principal Systems Verification Engineer | Hybrid

Olympus America, Inc.; Westborough (MA); Hybrid; USD 138,000 - 193,000; Full time

Benefits offered by this job

Competitive compensation

Annual bonus

401(k) with company match

Employee Assistance Program

Wellbeing programs

Paid vacation and sick time

Parental leave

Paid holidays

On-site daycare

Café and fitness center

Volunteer programs

Learning resources

Job summary

Olympus America, Inc. is seeking a senior System Verification professional in Massachusetts, Westborough. The role leads design verification plans, validates with cross-functional teams, and ensures compliance with medical device standards and regulatory requirements.

You will drive root-cause analysis, maintain documentation, and guide teams through ISO and GMP processes, with travel under 10% as needed. A strong background in high-assurance systems is essential.

Qualifications

• B.S. or M.S. in Computer Science, Mechanical or Electrical Engineering or similar related field.
• Minimum of 14 years of experience in System Verification of complex software and hardware systems.
• Minimum of 10 years of experience in System Verification of complex software and hardware systems with M.S.
• Minimum of 8 years of experience in System Verification of complex software and hardware systems with Ph.D.
• Minimum of 5 years of experience in System Verification under Medical Device Regulations.
• Experience with systems verification and user validation.
• General knowledge of medical device standards.
• Strong analytical and problem solving skills.
• Self-motivated person that can work individually and lead team projects.
• A self-starter with a strong desire to learn new concepts and adapt quickly.
• Ability to express ideas clearly both in written and oral communications.
• Ability to analyze technical requirements and develop well-structured architectures.
• Travel requirement: Less than 10%.

Responsibilities

• Lead, develop and execute system verification test plans and compile results.
• Participate in cross functional design reviews, hazard analysis and risk assessments.
• Contribute to root cause analysis for defects and drive process improvements.
• Communicate findings and recommendations within and outside the team.
• Report and resolve software bugs/issues using Defect Tracking System.
• Maintain projects and documentation per ISO and GMP guidelines.
• Ensure compliance with FDA QSR, ISO 13845, EUMDR in verification activities.
• Work in compliance with the Quality System and site rules.

Skills

System verification

Root cause analysis

Risk assessment

Defect tracking

Documentation

Regulatory compliance

Communication

Team leadership

Testing plans

Analytical skills

Education

B.S. or M.S. in Computer Science, Mechanical or Electrical Engineering or similar related field

Tools

Defect Tracking System

Job description

Olympus America, Inc. is seeking a senior System Verification professional in Massachusetts, Westborough. The role leads design verification plans, validates with cross-functional teams, and ensures compliance with medical device standards and regulatory requirements.

You will drive root-cause analysis, maintain documentation, and guide teams through ISO and GMP processes, with travel under 10% as needed. A strong background in high-assurance systems is essential.