Senior Principal Systems Engineer

Working Location: NATIONWIDE 

Workplace Flexibility: Hybrid

 

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. ​​

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Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

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Patient Focus, Integrity, Innovation, Impact and Empathy. 

 

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Job Description

The Staff R&D Systems Engineer leads and/or supports various Systems Engineering aspects on new product development efforts within the Digital Unit (DU) organization.  The major responsibilities of the position are performing and overseeing others perform activities such as defining product requirements and associated specifications, making system architecture decisions, defining interfaces and architecture of modular Software, outlining design inputs, product design implementation, verification testing and supporting design validation studies. The ideal candidate is a hands-on project and multi-disciplinary technical leader with a strong systems design, HW development, and integration background in a medical device environment.  The Principal Systems Engineer is a subject matter expert (SME) and provides project and engineering leadership in all phases of complex med-device development, as well as ensures compliance to applicable Design Controls, Product Security, and Cybersecurity policies. The individual may serve as a core or extended team member on PRP/NPD projects.

Areas of focus also include Systems aspects of identification of user needs, risk assessments, HW-SW integration and testing, as well as product and cybersecurity.

Extensive knowledge of medical device design control requirements, system design, software, hardware, digital image processing, integration testing, and design for manufacturability and testability is required.  Deep understanding of medical device standards, and experience in their application, is required.  This position is expected to provide leadership/mentorship to cross functional teams, and less experienced engineers/technicians.

Job Duties

• Provide project and technical leadership as it relates to Systems to cross functional teams including external partners for projects through conceptualization, development, product registration and commercialization.
• Establish and foster strong collaborative relationships with internal and external design/development partners, manufacturing partners and service providers. Provide critique and design guidance to ensure proper implementation and traceability of design outputs as compared to design inputs.
• Work closely with Product Managers in collection of user needs/feedback on product requirements and concepts
• Lead the requirements development and management process, incorporating risk management elements as required.
• Ensure compliance to product security and cyber security policies, and support efforts to author local SOP’s to ensure compliance.
• Support the optimization of design control elements to comply with medical device regulations.
• Implement product design with the intention of optimizing design for manufacturability and testability.
• Consider Cost of Goods and lifecycle when selecting components for device designs.
• Develop engineering solutions, investigate competing technologies while considering the patent landscape, and protect engineering solutions by filing timely invention disclosures and working closely with the IP Legal te