Olympus Corporation of the Americas

Principal Systems Verification Engineer

Olympus Corporation of the Americas

full-time

Posted on:

Location Type: Hybrid

Location: Westborough • Massachusetts • United States

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Salary

💰 $134,629 - $188,480 per year

Job Level

Lead

About the role

  • 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.

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%.
Benefits
  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
systems verificationtest plansroot cause analysisprocess improvementdefect trackingsoftware bug resolutionuser validationarchitectural developmentISO standardsGMP guidelines
Soft Skills
analytical skillsproblem solvingself-motivatedteam leadershipcommunication skillsadaptabilityclear expression of ideas
Certifications
B.S. in Computer ScienceM.S. in Mechanical EngineeringM.S. in Electrical Engineering