Staff Systems Engineer

Noah Medical; San Carlos (CA); On-site; USD 158,000 - 200,000; Full time

Job summary

Noah Medical is seeking a Staff Systems Engineer to lead the development of innovative surgical robotic systems. This high-impact role involves defining system architectures, managing requirements, and ensuring compliance with regulatory standards. The ideal candidate will have extensive experience in systems engineering within the medical device industry and a strong ability to communicate complex concepts effectively.

Benefits

Comprehensive health insurance including Medical, Dental and Vision

Equity & Bonus Program

Paid parental leave

12+ paid holidays, 15-20 days of PTO

Learning & Development Opportunities

Qualifications

• 10+ years of experience in systems engineering, preferably in medical devices.
• Experience with Class II or III medical devices.
• In-depth knowledge of regulatory standards.

Responsibilities

• Provide technical leadership and expertise in systems engineering.
• Conduct risk analyses and ensure compliance with regulatory standards.
• Coordinate integration of subsystems for cohesive performance.

Skills

Analytical skills

Problem-solving

Communication

Systems thinking

Education

Bachelor's or Master's degree in Systems Engineering, Mechanical Engineering, Electrical Engineering, Biomedical Engineering

Tools

Requirements management tools (JAMA, DOORS)

Job description

Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple indications. We are looking for exceptional engineers and key team members. Our incredibly talented team of engineers, innovators, and industry leaders bring years of experience from the top healthcare companies in the world, including: Intuitive, Auris, Stryker, Johnson & Johnson, Boston Scientific, Verb Surgical, Mako, Think Surgical, Medrobotics, and Hansen. We are looking for talented, motivated and ambitious team members to revolutionize robotic surgery.

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 OurStaff 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

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Pay Transparency

The Pay Range for this position is listed. Noah Medical offers a comprehensive benefits package including: competitive pay, health insurance, 401K and stock purchase plans, tuition reimbursement, paid time off plus holidays, and a flexible approach to work with remote, hybrid, field or office work schedules. Actual pay will be adjusted based on an individual's skills, experience, education, and other job-related factors such as location as permitted by law. Total compensation may also include additional forms of incentives.

$158,400 - $200,000 USD

Benefits & Perks (For Full Time Employees):

• 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
• Learning & Development Opportunities: On-demand online training and book reimbursement
• Team building and company organized social and celebration events

Noah Medical may offer remote, hybrid, or onsite work arrangements within the state of California depending on the specific team and/or role where applicable.

Noah Medical is an Equal Opportunity Employer. We celebrate diversity and are committed to ensuring an inclusive environment for our employees. Applicants are considered for all positions without regard to race, color, religion, sex or gender, gender identity or expression, sexual orientation, national origin, ancestry, age, genetic information, physical or mental disability, marital or protected military or veteran status, or any other consideration made unlawful by federal, state or local laws.

NO AGENCIES PLEASE - Please do not outreach to any managers or submit any resumes without a signed agreement from Talent Acquisition. Resumes shared with anyone at Noah Medical without a signed agreement will be considered your gift to us and no fee will be paid .

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