Principal Systems Verification Engineer

Olympus Corporation of the Americas•Westborough, MA

4d•Hybrid

About The Position

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.

Requirements

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; 10 years of experience with M.S, 8 years 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

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.