Staff, Systems Engineer

Working Location: MASSACHUSETTS, WESTBOROUGH 

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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Our five Core Values empower us to achieve Our Purpose: 

 

Patient Focus, Integrity, Innovation, Impact and Empathy. 

 

Learn more about Life at Olympus.

 

 

Job Description

The System Systems Engineer leads and/or supports all Systems Engineering aspects on new product development efforts within the Olympus Surgical Technologies of America (OSTA) organization.  Their primary focus shall be NPD projects and the impacts that they have on the system deliverables. The major responsibilities of the position are performing and overseeing others perform activities such as defining system requirements, Sub-system requirements and software requirements and the associated specifications, making system architecture decisions, outlining design inputs, product design implementation, verification testing and supporting design validation studies. The ideal candidate is a hands-on technical leader with a strong systems design and integration background. (Knowledge of HW, SW and system integration) The Staff 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. (IEC62304, IEC81001-5-1, IEC62366, etc The individual shall serve as a core team member on PRP/NPD projects.

The Staff Systems Engineer is expected to drive design/concept trade-off decisions while taking costs, technical risk, reliability and User Needs into consideration. She / He must fully understand medical device design control requirements, have experience leading technical development efforts, and be effective at communicating advancements and issues to all levels of the organization.

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 Marketing in collection of user needs/feedback on product requirements and concepts.
• Lead the requirements development and management process, incorporating risk management elements as required.
• Provide leadership on detailed design, requirements, architecture and data analysis.
• Experienced in developing User and Product Requirements.
• Experienced in planning Design Verification and Validation efforts to ensure the product effectively meets all requirements and applicable standards.
• Capable of effectively communicating with Core Team and Extended Team Members, while ensuring all R&D deliverables are completed with a high degree of quality, and attention to detail.
• Collaborates on the development of the technical development schedule and monitors Ensure compliance to product security and cyber security policies, and support efforts to author local SOP’s to ensure compliance. (IEC81001-5-1, IEC62304).
• 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 team as needed.
• Establish a