Principal Systems Verification Engineer

Olympus Corporation; Massachusetts; Hybrid; USD 138,000 - 193,000; Full time

Benefits offered by this job

Competitive salary

Annual bonus

401(k) with company match

On-site facilities

Job summary

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.

Qualifications

• 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%.

Responsibilities

• 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.

Skills

System Verification

Analytical skills

Communication

Leadership

Education

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

Tools

Defect Tracking System

Job description

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 of patient 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.

Learn more about Life at Olympus: https://www.olympusamerica.com/careers .

Job Description

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%.

Why join Olympus?

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
• Comprehensive medical, dental, vision coverage effective on start date
• 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
• Paid Educational Assistance
• US Only
• Center Valley, PA and Westborough, MA

Are you ready to be a part of our team?

Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks .

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 to plan eligibility and other 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. We warmly encourage all who wish to bring their talents to Olympus to apply.

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.