Systems Engineer

Vaco by Highspring; Dublin (OH); On-site; USD 120,000 - 160,000; Full time

Job summary

Highspring LLC (d/b/a Vaco by Highspring) seeks a seasoned Systems Engineer/Design Assurance professional to lead architecture, risk management, and V&V for a next-generation robotic medical device platform.

You will partner with multiple teams to ensure safety, traceability, and regulatory compliance across the product lifecycle, including FDA submissions and design controls.

Qualifications

• Bachelor's degree in a technical field is required; advanced degree is a plus.
• 8+ years of experience in systems engineering or design assurance for FDA-regulated devices.
• Experience guiding products through verification and validation and 510(k) submissions.
• Strong grasp of design controls, risk management, and regulatory documentation.
• Hands-on knowledge of 21 CFR 820.30 / FDA QMSR and traceability.
• Ability to work across hardware, software, electrical, mechanical, and controls teams.
• Familiarity with ISO 14971, ISO 13485, IEC 60601, IEC 62304, IEC 62366; MBSE and SysML valued.

Responsibilities

• Establish and manage a risk-based systems engineering and design process across development lifecycle.
• Translate user and clinical needs into verifiable system requirements with acceptance criteria.
• Own system architecture and define interfaces across subsystems (mechanical, electrical, firmware, software, controls).
• Develop and maintain Interface Control Documents (ICDs) for data, power, and mechanical interfaces.
• Maintain requirements traceability from user needs through system requirements and verification.
• Lead risk management activities per ISO 14971 including FMEA and residual risk assessment.
• Develop and manage V&V strategy, protocols, and traceable verification evidence.
• Ensure design outputs are verified against inputs with complete results and DHF upkeep.
• Lead design reviews, stage-gate activities, and action-item closure.
• Ensure compliance with medical-device standards (IEC 60601, IEC 62304, IEC 62366, ISO 13485, ISO 14971).
• Coordinate cross-functional troubleshooting and system bring-up to resolve failures.
• Establish and maintain configuration management, requirement management, and test management processes.
• Collaborate with quality and regulatory teams for submission-ready documentation (FDA 510(k)).

Skills

Systems Engineering

Medical Devices

Design Assurance

FDA 510(k)

Design Controls

Requirements Engineering

ISO 14971

ISO 13485

IEC 60601

IEC 62304

IEC 62366

Verification & Validation

Risk Management

System Architecture

Interface Control

System Integration

Robotics

Medical Imaging

MBSE

SysML

ALM

eQMS

Education

Bachelor's degree in Systems Engineering, Electrical Engineering, Mechanical Engineering, Robotics, or a related technical discipline

Tools

Jama

Polarion

Greenlight Guru

DOORS

Job description

Location: Dublin, OH
Work Arrangement: Onsite
Job Type: Full-Time

About the Role

We are seeking an experienced Systems Engineer / Design Assurance professional to lead systems engineering, system architecture, and design assurance for a next-generation robotic medical device platform.

This is a hands-on technical role responsible for establishing a robust, risk-based development process and ensuring that safety, verification, traceability, and regulatory requirements are incorporated throughout the product development lifecycle.

The ideal candidate brings strong systems engineering expertise combined with deep experience in FDA-regulated medical devices, design controls, risk management, verification and validation (V&V), and regulatory submissions.

You will work closely with mechanical, electrical, software, controls, clinical, quality, and regulatory teams to develop an integrated product that meets system-level performance, safety, and compliance requirements.

Key Responsibilities

• Establish and manage a risk-based systems engineering and design process throughout the product development lifecycle.
• Translate user and clinical needs into clear, measurable, and verifiable system requirements with defined acceptance criteria.
• Own system architecture and define interfaces across mechanical, electrical, firmware, software, controls, and imaging subsystems.
• Develop and maintain Interface Control Documents (ICDs) covering data, power, mechanical, and other system interfaces.
• Build and maintain requirements traceability from user needs through system requirements, design outputs, and verification testing.
• Lead risk management activities in accordance with ISO 14971, including hazard analysis, FMEA, risk evaluation, mitigation, and residual-risk assessment.
• Develop and manage the Verification & Validation (V&V) strategy and program, including protocols, reports, test execution, and traceable verification evidence.
• Ensure design outputs are verified against applicable design inputs with complete and documented results.
• Own and maintain the Design History File (DHF) and design-control documentation.
• Lead formal design reviews, phase-gate activities, and action-item closure.
• Establish and maintain compliance with applicable medical-device standards, including IEC 60601, IEC 62304, IEC 62366, ISO 13485, and ISO 14971.
• Lead system integration and product bring-up, troubleshooting cross-functional technical issues and driving resolution of system-level failures.
• Establish requirements management, configuration management, design review, and test-management processes and tools.
• Track systems engineering and design-control activities against overall product development schedules.
• Partner with quality and regulatory teams to prepare complete, submission-ready design-control and V&V documentation for FDA regulatory submissions, including 510(k).
• Identify design risks and compliance gaps early and drive corrective actions before design freeze and formal verification.

Required Qualifications

• Bachelor's degree in Systems Engineering, Electrical Engineering, Mechanical Engineering, Robotics, or a related technical discipline. Advanced degree is a plus.
• 8+ years of experience in systems engineering, systems design, or design assurance within FDA-regulated medical devices.
• Demonstrated experience taking medical-device products through verification and validation and into or through a 510(k) or comparable regulatory submission.
• Strong understanding and practical application of medical-device design controls and design assurance.
• Hands-on experience with 21 CFR 820.30 / FDA QMSR, requirements traceability, risk management, and V&V.
• Experience working across hardware, software, electrical, mechanical, and controls disciplines.
• Strong understanding of system architecture, requirements engineering, interface definition, and system integration.
• Practical knowledge of ISO 14971, ISO 13485, IEC 60601, IEC 62304, and IEC 62366.
• Experience developing verification strategies, test plans, protocols, reports, and system-level integration testing.
• Strong technical writing skills with the ability to produce clear, complete, and audit-ready engineering and regulatory documentation.
• Ability to work effectively in an evolving development environment and establish systems engineering processes where formal processes may still be developing.
• Strong analytical, problem-solving, communication, and cross-functional collaboration skills.

Preferred Qualifications

• Experience with robotics, motion control, or real-time control systems.
• Experience with cardiac imaging, ultrasound, or other medical imaging technologies.
• Experience integrating or qualifying third-party OEM hardware, particularly medical imaging equipment.
• Familiarity with premarket cybersecurity requirements for connected medical devices.
• Experience with requirements, ALM, or eQMS platforms such as Jama, Polarion, Greenlight Guru, or DOORS.
• Experience with Model-Based Systems Engineering (MBSE) and SysML.
• Quality or regulatory certifications such as ASQ CQE, CQA, or RAC.
• Previous experience working in an early-stage medical-device or medtech environment.

Key Skills

Systems Engineering | Medical Devices | Design Assurance | FDA 510(k) | Design Controls | Requirements Engineering | Requirements Traceability | ISO 14971 | ISO 13485 | IEC 60601 | IEC 62304 | IEC 62366 | Verification & Validation | Risk Management | FMEA | System Architecture | Interface Control | System Integration | Robotics | Medical Imaging | ALM | eQMS | SysML | MBSE

Equal Opportunity Notice

Highspring LLC (d/b/a Vaco by Highspring) and its parents, affiliates, and subsidiaries ("we," "our," or "Vaco by Highspring") are committed to the full inclusion of all qualified individuals and does not discriminate against any employee or applicant for employment because of race (including but not limited to traits historically associated with race such as hair texture and hair style), color, sex (includes pregnancy or related conditions), religion or creed, national origin, citizenship, age, disability, status as a veteran, union membership, ethnicity, gender, gender identity, gender expression, sexual orientation, marital status, political affiliation, or any other protected characteristics as required by applicable law. The company is also committed to ensuring that persons who need them are provided with reasonable accommodations; if an accommodation is needed to participate in the job application or interview process, please contact [e-mail] .

Privacy Notice

Vaco by Highspring respects your privacy and are committed to providing transparent notice of our policies.

• California residents may access Vaco by Highspring HR Notice at Collection for California Applicants and Employees here.
• Virginia residents may access our state specific policies here.
• Residents of all other states may access our policies here.
• Canadian residents may access our policies in English here and in French here.
• Residents of countries governed by GDPR and UK GDPR may access our policies here.

Additionally, submissions to this position are subject to the use of AI to perform preliminary candidate screenings, focused on ensuring minimum job requirements noted in the position are satisfied. More details about Vaco by Highspring's use of AI can be found here (https://www.highspring.com/ai-use-notices/). Further assessment of candidates beyond this initial phase will be conducted by recruiters and hiring managers. Vaco by Highspring does not know and cannot opine on if its client's use of AI products in hiring.

Pay Transparency Notice

Determining compensation for this role (and others) at Vaco by Highspring depends upon a wide array of factors including but not limited to:

· the individual's skill sets, experience and training;

· licensure and certification requirements;

· office location and other geographic considerations; and

· other business and organizational needs.

With that said, as required by local law, Vaco by Highspring believes that the following salary range referenced above reasonably estimates the base compensation for an individual hired into this position in geographies that require salary range disclosure. The individual may also be eligible for discretionary bonuses and/or participation in medical, dental, and vision benefits as well as the company's retirement plan (or similar retirement benefits).