Systems Engineer

Working

Location:

Massachusetts, Westborough
Workplace Flexibility: Hybrid

The Staff 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 is on NPD projects and the impacts that they have on system deliverables. They perform and oversee activities such as defining system, sub‑system, and software requirements, making system architecture decisions, outlining design inputs, implementing product design, conducting verification testing, and supporting design validation studies.

The ideal candidate is a hands‑on technical leader with a strong systems design and integration background (hardware, software, and system integration). The Staff Systems Engineer is a subject matter expert and provides project and engineering leadership in all phases of complex medical‑device development, ensuring compliance with applicable Design Controls, Product Security, and Cybersecurity policies (IEC 62304, IEC 81001‑5‑1, IEC 62366, etc.).

They serve as a core team member on PRP/NPD projects and drive design/concept trade‑off decisions while considering cost, technical risk, reliability, and user needs.

• Provide project and technical leadership for Systems to cross‑functional teams, including external partners, 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 compared to design inputs.
• Work closely with Marketing to collect 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.
• Develop User and Product Requirements.
• Plan Design Verification and Validation efforts to ensure the product meets all requirements and applicable standards.
• Communicate effectively with Core Team and Extended Team Members, ensuring all R&D deliverables are completed with high quality and attention to detail.
• Collaborate on the development of the technical development schedule and monitoring.
• Ensure compliance with product security and cyber security policies, and support efforts to author local SOPs (IEC 81001‑5‑1, IEC 62304).
• Support the optimization of design control elements to comply with medical device regulations.
• Design with manufacturability and testability in mind.
• Consider cost of goods and lifecycle when selecting components for device designs.
• Develop engineering solutions, investigate competing technologies, and protect solutions by filing timely invention disclosures and working with the IP Legal team.
• Establish and maintain detailed project plans, define risks, and recommend contingency plans as required.
• Support Risk Management activities, working with Design Assurance.
• Lead all technical project execution activities and oversee the development of statistically sound design verification protocols and reports, design validation, and delivery system qualification activities.
• Lead the system safety certification process to standards such as EN 60601‑1, EN 60601‑1‑2, and ensure software is developed in compliance with EN 62304.
• Provide technical support to Marketing for technical brochures, training programs, and technical presentations to customers and the sales force.
• Maintain knowledge of the technical product landscape, competitive products, and procedural trends for target procedural areas.
• Provide technical updates to systems leadership and R&D Core Team Members via weekly discussions and monthly updates.
• Prioritize and organize work/efforts based on project priorities.
• Support robust design analysis, such as tolerance stack‑ups, edge‑of‑failure testing, spec evaluations, risk analysis, and statistical evaluations to ensure performance and quality.
• Proactively ideate and lead technical risk…