Working Location: Massachusetts, Westborough Workplace Flexibility: HybridJob DescriptionUnder 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 QualificationsRequired:- 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.
