Senior System Verification Engineer

Working Location: MASSACHUSETTS, WESTBOROUGH

Workplace Flexibility: Hybrid

Are you looking for a company that cares about people's lives and health, including yours? Let's inspire healthier lives, together.

Olympus, a leading medical technology company, has focused on making people's lives better for over 100 years.

Our Purpose is to make people's lives healthier, safer, and more fulfilling.

Our Core Values are reflected in all we do: Integrity - Empathy - Agility - Unity - Long-Term View

We deliver on our purpose and our core values by staying True to Life.

Job Description

Under direction of the Director of Research and Development Excellence, 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 developing and executing 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.
• Monitors and mentors V&V Engineers I and II as required.
• 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.
• Participate in society meetings, focus groups, and User Site Testing (UST) activities to support continuous process improvement of verification and workflow validation testing.
• 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 5 years of experience in System Verification of complex software and hardware systems.
• Minimum of 3 years of experience in System Verification under Medical Device Regulations.
• Travel requirement: Less than 10%

Preferred:

• Experience with systems verification and user validation. Full understanding of workflows and user needs.
• 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.

#LI-Hybrid

Why join Olympus?

Here, people matter-our health, our happiness, and our lives.

• Competitive salaries, annual bonus and 401(k)* with company match
• Comprehensive Medical, Dental, Visions coverage effective on start date
• 24/7 Employee Assistance Program
• Free virtual live and on-demand wellness classes
• Work-life balance supportive culture with hybrid and remote roles
• 12 Paid Holidays
• Educational Assistance
• Parental Leave and Adoption Assistance
• Volunteering and charitable donation match programs
• Diversity & Inclusion Programs including Colleague Affinity Networks
• On-Site Child Daycare, Cafe, Fitness Center**

* US Only

* *Limited locations

We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you. Learn more about our benefit offerings at https://www.olympusamerica.com/careers/benefits-perks.

About us:

Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety.

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.

Olympus is dedicated to building a diverse, inclusive and authentic workplace

We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.

Let's realize your potential, together.

Olympus requires all US new hires to be "fully vaccinated" against COVID-19, as defined by the Centers for Disease Control and Prevention (CDC), on or before their first day of work. Individuals who have been offered employment who have a disability, medical condition, or sincerely-held religious belief that prevents them from being vaccinated against COVID-19 are required to request and be granted a reasonable accommodation prior to their first day of work.

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 ||

Nearest Major Market: Worcester

Job Segment:

R&D Engineer, Testing, Medical Device Engineer, Business Process, Electrical Engineering, Engineering, Technology, Management