Senior Analyst creating System Integration solutions to support business needs at Eversource. Engaging with customers to develop actionable business intelligence reports and enterprise reporting.
About the role
- Senior Systems Engineer driving system engineering activities within Life Cycle Engineering for a medical device company. Leading cross-functional collaboration and ensuring compliance with medical device regulations.
Responsibilities
- Serve as a key member of a cross-functional project team consisting of electrical, software, mechanical, manufacturing, and quality engineers to achieve project deliverables
- Serves as a system technical expert for design changes to subsystems by driving requirement refinement, performing risk reviews, implementing risk mitigations, and developing system verification plans to verify the design change
- Perform functional analysis, timeline analysis, and detailed trade-off studies to drive design improvements and cost-reduction to existing subsystems
- Troubleshoot system-level issues, perform root cause analysis, and implement effective solutions throughout the development process
- Lead risk management activities, including hazard identification and Failure Modes and Effects Analysis (FMEA)
- Ensure that all design and development activities comply with regulatory requirements, including FDA Quality System Regulation (QSR) 21 CFR Part 820, ISO 13485, and IEC 60601
- Work closely with regulatory affairs and quality assurance teams to prepare and maintain the Design History File (DHF) and other technical documentation for regulatory submissions
- Support external audits conducted by regulatory bodies such as the FDA or Notified Bodies
- Develop, author, and execute comprehensive test plans, protocols, and reports for system integration, verification, and validation
- Provide technical support and expertise to cross-functional teams for post-market surveillance and continuous improvement activities
- Manage device and manufacturing process changes, including documentation updates and risk file maintenance
- Guide and offer expertise with peers, providing guidance on systems engineering processes and tools.
Requirements
- Bachelor degree required (preferred field of study: Biomedical, Electrical, Mechanical, Systems)
- M.S. (preferred field of study: Engineering, Engineering Management) considered a plus
- 4+ years of experience working in the medical device industry/ highly regulated product development industry
- 6+ years of experience working directly in a Systems Engineering discipline within product development
- Proficiency in system-level design, requirements management, and architectural development
- Solid understanding of medical device regulations (FDA QSR, ISO 13485) and risk management (ISO 14971)
- Experience with requirements management software (e.g., Jama, Polarion, Doors) is required
- Experience with systems verification/validation, including test method development
Benefits
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO)
- And additional employee wellness programs
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