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Senior Systems Engineer
2 months ago
The Sr. Systems Engineer will be responsible for supporting the systems engineering function for complex medical devices, specifically our implantable Spinal Cord Stimulator (SCS) System. This position requires knowledge of the technical processes of medical device systems engineering to cover the whole system life cycle, which includes conceptualizing/planning, determining stakeholder needs and requirements, creating systems requirements, creating system architecture (spanning across electrical, firmware, and mechanical disciplines), contributing to the design of features spanning across multiple disciplines, analyzing requirements (clarity, implementable, testable, etc.), implementation (working with design software to execute requirements), performing system integration analysis & testing, and performing verification & validation (V&V). This role requires a strong background in medical device development (understanding regulatory compliance, design controls, and change management), systems engineering principles (e.g., risk management), and a track record of successful project management.
The Sr. Systems Engineer will work with software, hardware, mechanical, and research engineers to ensure system requirements and complex system interactions will appropriately be met. The role will further contribute to the organization through troubleshooting support (as the need arises) and assisting with development activities (both internally and with external suppliers/vendors), as required.
Essential Duties and Responsibilities:
- Participate in requirements writing, management, and analysis. Participate in risk analysis, hazard analysis, product test and evaluation. Execute system V&V, and design control documentation.
- Gathers, understands, and analyzes input/output requirements from stakeholders for medical devices and device features. Translates information into specific system features. Contributes to project planning. Generates and applies literature, patents, and current practices to solve issues.
- Synthesizes gathered information together with technical and regulatory constraints to define a system and the system behavior, resulting in a system specification.
- Participates in generation and execution of formative and summative studies to ensure alignment with user needs and product usability.
- Evaluate prototypes formally and informally through structured and ad hoc testing. Test aspects of new projects or algorithms to evaluate prototypes and validate output to meet intended requirements. Collect, organize, analyze, and document test results.
- Collaboratively plan, design, develop, troubleshoot/debug and drive integration at the intersection of software, hardware, mechanical, and research within our complex systems.
- Foster a culture of innovation, collaboration, and continuous improvement.
- Communicate effectively and participate on cross functional development teams. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Contribute and lead aspects of integration and V&V at the system level.
- Comply with Presidio Medical's quality system requirements as well as any applicable regulatory requirements.
- Comply with all health and safety regulations, policies, and work practices.
- Other duties as assigned.
Experience:
- Minimum of 7 years (5 years with advanced degree) development in safety oriented regulated industries, such as medical, automotive and defense.
- Strong understanding of medical device development processes, regulations, and quality Standards. Experience with ISO62304, IEC60601, ISO14708, and ISO13485.
- Proven track record of successfully managing/navigating complex, cross-functional projects from initiation to completion.
- Excellent communication, presentation, written, and interpersonal skills.
- Exceptional problem-solving abilities and the capacity to make decisions under pressure.
- Ability to work in a fast paced, team environment, meet deadlines, and prioritize and balance work for multiple individuals.
- Intrinsically motivated, and detail oriented with profound problem-solving abilities.
- Bachelor's degree (higher degree preferred) in Electrical Engineering, Computer Engineering, Computer Science, Software Engineering, Systems Engineering, or related fields required.
- Varied sitting, standing, and walking.
- Ability to lift and carry 20lbs. or less.
- The candidate will work out of the San Mateo office.
- This role is not eligible for sponsorship.
