What are the responsibilities and job description for the Staff Systems Engineer position at Noah Medical?
About The Team:
The Staff Systems Engineer will be a technical leader and expert contributor responsible for driving the development and integration of complex surgical robotic systems. This individual will work closely with cross-functional teams to define system-level architectures, manage requirements, oversee risk analysis, and ensure compliance with regulatory standards. This is a high-impact role that requires strategic thinking, problem-solving, and technical expertise to deliver world-class medical devices.
A Day In The Life Of Our Staff Systems Engineer:
- Technical Leadership: Provide deep technical expertise and act as a subject matter expert in systems engineering principles to drive innovative solutions for surgical robotic platforms.
- System Architecture and Requirements: Define, develop, and refine system-level architectures and requirements, ensuring traceability and alignment with stakeholder needs and regulatory requirements.
- Risk Management: Conduct and lead system-level risk analyses (e.g., FMEA, FTA) to proactively identify and mitigate risks, ensuring compliance with ISO 14971.
- Design Integration: Coordinate the integration of mechanical, electrical, software, and clinical subsystems to ensure cohesive and robust system performance.
- Verification and Validation: Develop, plan, and execute system verification and validation activities to confirm product safety and efficacy.
- Collaboration and Communication: Serve as a liaison between engineering, clinical, quality, regulatory, and program management teams, ensuring alignment and effective communication throughout product development.
- Regulatory Compliance: Prepare and review technical documentation, including design history files, risk management files, and support for regulatory submissions (e.g., FDA 510(k), EU MDR).
- Continuous Improvement: Drive process improvements and best practices within the systems engineering function to enhance efficiency and effectiveness.
About You:
- Bachelor's or Master's degree in Systems Engineering, Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or related field.
- 10 years of experience in systems engineering, preferably within the medical device industry or similarly regulated environments.
- Demonstrated experience contributing to the development and successful launch of Class II or III medical devices.
- Proficient in requirements management tools such as JAMA, DOORS, or similar.
- In-depth knowledge of standards such as 21 CFR 820, ISO 13485, ISO 14971, IEC 60601, and IEC 62304.
- Strong analytical skills with a systems-thinking approach to solving complex technical challenges.
- Excellent verbal and written communication skills to effectively convey complex technical concepts to diverse audiences.
- Strong problem-solving skills and ability to work in dynamic, cross-functional teams.
- High attention to detail and organizational skills to manage multiple priorities and deliverables.
- Self-motivated, adaptable, and capable of working independently while collaborating across disciplines.
- Willingness to travel domestically or internationally up to 20% of the time
Workplace Type: Onsite
Benefits & Perks (For Full Time Employees):
- Competitive Salary
- Comprehensive health insurance including Medical, Dental and Vision HSA and FSA options
- Equity & Bonus Program
- Life Insurance (company paid & supplemental) and Disability insurance
- Mental health support through medical insurance programs
- Legal and Pet Insurance
- 12 paid holidays, 15-20 days of PTO use-what-you-need sick days
- Paid parental leave
- In-office snacks and beverages
- In-office lunch stipend
- Learning & Development Opportunities: On-demand online training and book reimbursement
- Team building and company organized social and celebration events
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