Principal Systems Verification Engineer

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

Select how often (in days) to receive an alert: Create Alert

Working Location:Massachusetts, Westborough

Workplace Flexibility:Hybrid

For more than 100 years,Olympus has focused on making people’s lives healthier, safer and more fulfilling.

Every day, we live by our philosophy,True to Life, by advancing medical technologies and elevating the standard ofpatient care so people everywhere can fulfill their desires, dreams, and lives.

Our five Core Values empower us to achieve Our Purpose:

Patient Focus, Integrity, Innovation, Impact and Empathy.

Under direction of the Director of Research and Development Excellence and Systems Verification, this position is responsible for leading the design, development, documentation and execution of system verification & validation plans, schedules, test protocols and reports to ensure Olympus products meet published user and system requirements and are compliant with Quality System Regulations.

Job Duties

• Responsible for leading, developing and executing systems verification test plans and compiling results in accordance with Olympus DC Standard Operating Procedures.
• Participates in extended cross functional team supporting design reviews, hazard analysis and risk assessments to ensure high standards are met.
• Participates in root cause analysis for defects and provides process improvement suggestions to eliminate future occurrences of similar defects
• Effectively communicate and present findings, problems, and solutions within the team, organization, and outside the organization including recommendations for actions and prioritization
• Using Defect Tracking System, report and/or resolve software bugs/issues.
• Maintain projects and documentation according to ISO and GMP guidelines, while following the Olympus DC Product Development process.
• Maintains current knowledge to ensure compliance to applicable regulatory and corporate domestic and international standards/requirements (e.g., FDA QSR, ISO 13845, EUMDR) as they apply to verification and validation activities of the Design Control process.
• All activities must be performed in compliance with the Quality System
• Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations
• All other duties as assigned.

Job Qualifications

Required:

• 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%.

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.

Equitable Offerings you can count on:

Competitive salaries, annual bonus and 401(k)* with company match

24/7 Employee Assistance Program

Free live and on-demand Wellbeing Programs

Generous Paid Vacation and Sick Time

Paid Parental Leave and Adoption Assistance*

12 Paid Holidays

On-Site Child Daycare, Café, Fitness Center**

Connected Culture you can embrace:

Work-life integrated culture that supports an employee centric mindset

Offers onsite, hybrid and field work environments

Paid volunteering and charitable donation/match programs

Employee Resource Groups

Dedicated Training Resources and Learning & Development Programs

The anticipated base pay range for this full-time position in this location is$137,657.00-$192,722.00/ year, plus potential for annual bonus(subject toplan eligibility andother requirements).

Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.

At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.

For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.

Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com .

You Belong at Olympus

We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish.

Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed , please contact [e-mail]. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

Let’s realize your potential, together.

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough ||Research and Development