Systems Verification Engineer II at Olympus focusing on the development and execution of system verification to ensure product compliance. Collaborate with cross-functional teams to meet regulatory standards and product requirements.
Responsibilities
Responsible for developing and executing systems verification test protocols and compiling results in accordance with Olympus DC Standard Operating Procedures.
Contributes to product development projects and/or technology development efforts.
Participates in extended cross functional teams supporting design reviews, hazard analysis and risk assessments to ensure high standards are met.
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.
Supports algorithm testing associated with TDP projects.
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, Engineering or similar related field
Minimum of 2 years of related experience with BS (0 years with MS)
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
Benefits
Competitive salaries, annual bonus and 401(k)* with company match
Comprehensive medical, dental, vision coverage effective on start date
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