Systems Engineer Medical Devices Jobs Near Me

About the Opportunity

A venture-backed robotics company developing an advanced, AI-enabled medical technology platform is seeking a Staff Systems Engineer to own systems engineering and design assurance for a complex robotic medical device.

This is a highly influential, hands-on role for a seasoned systems engineer who can operate at the intersection of system architecture, hardware, software, controls, risk management, verification and validation, and FDA design controls.

You will own the architecture and requirements that flow through the system, the interfaces between subsystems, the risk management framework, the V&V program, traceability, and the Design History File. More importantly, you will help establish how the engineering organization builds, bringing risk-based thinking into design decisions from the beginning so that safety, verifiability, and standards conformance are engineered into the product rather than discovered late in development.

This is not a downstream quality or documentation role. You will work directly alongside mechanical, electrical, software, controls, clinical, quality, and regulatory stakeholders, guiding architecture and design decisions while helping advance the platform toward regulatory submission and commercialization.

The position is on-site in the Columbus, Ohio area and reports directly to senior engineering leadership.

What You’ll Do

• Establish and lead a risk-based systems engineering process, driving identified hazards to documented mitigation before design freezes so issues surface during engineering and design review rather than late in V&V or audit.
• Translate user and clinical needs into verifiable engineering specifications with clearly defined acceptance criteria, including performance targets, power budgets, dimensional and weight constraints, applied-force limits, and safety requirements.
• Own the system architecture for a complex robotic medical platform spanning mechanical systems, electronics, embedded systems, firmware, software, controls, sensing, and third-party medical equipment.
• Define and manage subsystem interfaces, authoring interface control documentation for data, power, electrical, software, and mechanical boundaries to reduce integration risk and prevent cross-domain failures.
• Build and maintain end-to-end requirements traceability, linking user needs to system requirements, design outputs, risk controls, and verification evidence with complete coverage and no orphan requirements.
• Lead risk management activities under ISO 14971, including hazard analysis, FMEAs, risk-control definition, mitigation traceability, residual-risk evaluation, and verification of risk-control effectiveness.
• Own the verification and validation program, including V&V strategy, planning, protocol development, execution oversight, reporting, and traceable verification of design outputs against design inputs.
• Own and mature the Design History File and design-control process, leading phase-gate design reviews, documenting action closure, and helping transition critical systems and design-assurance capabilities from external support into the internal organization.
• Establish and verify conformance to applicable medical-device standards, including the IEC 60601 family, IEC 62304, IEC 62366, ISO 13485, and ISO 14971.
• Lead system integration and bring-up, working hands-on with engineering teams to root-cause failures that cross mechanical, electrical, software, firmware, sensing, and controls boundaries.
• Establish configuration management, requirements management, design review, and test-management infrastructure appropriate for a growing regulated robotics organization.
• Partner closely with regulatory strategy to deliver a complete, submission-ready design controls and V&V evidence package supporting a 510(k) pathway.
• Help anchor the systems engineering discipline as the company scales, establishing practical methods, tools, decision frameworks, and engineering rigor without creating unnecessary bureaucracy.

About You

• Bachelor’s degree in Systems Engineering, Electrical Engineering, Mechanical Engineering, Robotics, or a related technical discipline. An advanced degree is a plus.
• 8+ years of experience in systems engineering, systems integration, or design assurance for FDA-regulated medical devices, ideally Class II or higher.
• Direct experience taking complex products through verification and validation and into or through a 510(k) or comparable regulatory submission.
• A genuinely dual-strength background combining:
  • The engineering depth to guide architecture, interfaces, integration, and technical tradeoffs; and
  • Deep command of design controls, traceability, risk management, V&V, and regulated product development.
• Strong working knowledge of FDA design controls and QMSR expectations, including requirements management, design inputs and outputs, traceability, design reviews, risk controls, and objective verification evidence.
• Hands-on technical fluency across hardware, software, embedded systems, and controls, with the ability to integrate across disciplines and debug failures at system boundaries.
• Practical experience applying relevant standards, including:
  • IEC 60601
  • IEC 62304
  • IEC 62366
  • ISO 13485
  • ISO 14971
• Demonstrated ability to define and drive a complete verification and validation strategy, including test planning, requirement verification, system integration testing, protocol development, execution, and reporting.
• Strong technical writing skills with the ability to author clear, complete, and audit-ready specifications, protocols, reports, risk documentation, and traceability matrices.
• Comfort operating in an environment without a mature playbook. This role will help build the systems engineering discipline rather than simply inherit an established process.
• High intrinsic motivation, sound engineering judgment, and the ability to focus intensely on the technical and program risks that matter most.

Bonus Points

• Experience with robotics, robotic arms, motion control, force-controlled systems, or real-time controls.
• Experience with medical imaging, ultrasound, cardiac imaging, image-guided systems, or other complex diagnostic or therapeutic devices.
• Experience integrating or qualifying third-party OEM hardware within a regulated medical-device platform.
• Familiarity with current premarket cybersecurity expectations for connected medical devices.
• Experience with requirements, ALM, or eQMS platforms such as Jama, Polarion, Greenlight Guru, or DOORS.
• Familiarity with model-based systems engineering and SysML.
• Quality or regulatory certifications such as ASQ CQE, CQA, or RAC.
• Prior experience in an early-stage, venture-backed, or rapidly scaling medtech environment.

Why This Role Matters

This is an opportunity to shape the engineering foundation of a sophisticated robotic medical platform at a critical stage of development.  The successful candidate will not simply maintain systems documentation. You will influence how the product is architected, how risk is designed out, how interfaces are controlled, how evidence is generated, and how a multidisciplinary engineering organization builds a safe, verifiable, submission-ready system.

For a systems engineer who combines deep technical credibility with rigorous medical-device design assurance, this is a rare opportunity to build the discipline, influence the product, and help bring a meaningful robotic technology into clinical use.

Compensation

The anticipated base salary range is $143,000 to $203,000 annually, depending on experience and qualifications.

Benefits

• Equity: Company stock options.
• Insurance Coverage: medical, dental, and vision insurance available
• Unlimited PTO and a full winter shutdown
• Relocation Assistance: Relocation assistance is available to move you near facility in the Columbus, OH area