Senior System Engineer

Warwick Consulting; Boston (MA); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Warwick Consulting Limited is seeking a Senior Systems Engineer to drive systems engineering activities for medical device products, translating user needs into measurable design inputs and ensuring traceability throughout development. The role requires a strong DHF/design controls background and collaboration with Engineering, R&D, Quality, and Regulatory Affairs.

Ideal candidates will have 7+ years of experience, familiarity with Diagnostic Imaging systems, and the ability to coordinate across

Qualifications

• Bachelor’s degree in a technical discipline or equivalent experience.
• 7+ years in systems engineering, requirements, or design controls in medical devices.
• Strong ability to assess requirements quality for clarity, completeness, traceability, and testability.
• Experience building or maintaining system architecture and interfaces across multidisciplinary teams.
• DHF and design control experience including documentation review and remediation.

Responsibilities

• Elicit, clarify, document, and maintain user needs and system requirements for medical device capital equipment.
• Develop, document, and maintain system architecture, boundaries, interfaces, and design relationships.
• Coordinate with hardware, software, electrical, mechanical, imaging, and other engineering disciplines for cohesive system design.
• Maintain end-to-end traceability from user needs to verification evidence and DHF documentation.
• Support design reviews, milestones, audits, and remediation activities with cross-functional teams.

Skills

Design controls

Traceability

Systems engineering

Regulatory alignment

Cross-functional collaboration

Requirement management

Education

Bachelor’s degree in Systems or Biomedical/Electrical/Mechanical Engineering

Tools

PLM

Requirements management tools

Job description

Warwick Consulting is a comprehensive medical device and life sciences consulting firm that simplifies complexity across the full product lifecycle, from concept and design through regulatory approval, commercialization, and post-market support. We partner with organizations ranging from early-stage innovators to global industry leaders, delivering tailored, results-driven solutions across engineering, quality systems, regulatory affairs, cybersecurity, risk management, human factors engineering, product quality, and FDA remediation. By integrating deep industry expertise with innovative, AI-enabled solutions, including our VERA QMS Assurance platform, we help clients address complex challenges, strengthen compliance, improve operational efficiency, and accelerate innovation. Our experienced consultants provide flexible on-site, hybrid, and remote support, delivering the right expertise when and where it is needed most.

Position Overview

The Senior Systems Engineer will support systems engineering activities for medical device products, with responsibility for establishing clear user needs, translating them into high-quality design inputs and requirements, defining and maintaining system architecture, and ensuring end-to-end traceability throughout the product development lifecycle.

The ideal candidate has a strong Design Controls background and can partner with Engineering, R&D, Quality, Regulatory Affairs and other stakeholders to ensure system requirements are complete, consistent, verifiable, and appropriately linked to design outputs & verification evidence. Experience with Diagnostic Imaging systems is preferred.

This is a hybrid role requiring effective cross-functional collaboration and the ability to support project milestones, technical reviews, and design documentation activities.

Key Responsibilities

System Requirements and User Needs

Collaborate with customer-facing, product, and engineering stakeholders to elicit, clarify, document, and maintain user needs and intended uses.

Translate user needs into clear, complete, unambiguous, and testable system-level design inputs and technical requirements for medical device capital equipment.

Review requirements for quality attributes including clarity, consistency, feasibility, verifiability, traceability, and appropriate acceptance criteria.

Manage requirements and allocation across system components, subsystems, hardware, software, and interfaces, as applicable.

Identify requirement gaps, conflicts, assumptions, dependencies, and changes; facilitate resolution with relevant stakeholders.

System Architecture and Design Integration

Develop, document, and maintain system architecture, system boundaries, interfaces, and key design relationships.

Coordinate with hardware, software, electrical, mechanical, imaging, and other engineering disciplines to ensure cohesive system-level design and integration.

Assess the impact of design and requirements changes on architecture, interfaces, verification activities, risk management, and downstream documentation.

Support system-level trade-off analyses and technical decisions, documenting rationale and ensuring alignment with product needs and design constraints.

End-to-End Traceability and DHF

Establish and maintain bidirectional traceability from user needs through design inputs, system and subsystem requirements, design outputs, risk controls, and verification evidence, as applicable.

Support development, organization, review, and remediation of Design History File documentation to ensure it is complete, consistent, and inspection ready.

Identify and resolve traceability gaps, unsupported design inputs, and missing or inadequate verification links.

Partner with Quality and Regulatory Affairs to align systems engineering deliverables with design control procedures and applicable regulatory expectations.

Maintain accurate requirements records and change history using applicable requirements management, PLM, or document management tools.

Cross-Functional Collaboration

Facilitate requirements reviews, architecture reviews, interface discussions, and traceability assessments with multidisciplinary teams.

Work with Verification and Validation, Risk Management, Quality, and Regulatory Affairs to ensure requirements are testable and connected to appropriate evidence.

Communicate technical issues, requirement risks, and decisions clearly to engineering teams and project leadership.

Support design reviews, development milestones, audits, and remediation activities as needed.

Required Qualifications

Bachelor’s degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Computer Engineering, or a related technical discipline, or equivalent relevant experience.

With minimum 7+ years of experience in systems engineering, systems requirements, product development, or design controls within the medical device industry.

Strong experience defining and managing user needs, design inputs, system requirements, and design outputs in a regulated product development environment.

Demonstrated ability to assess requirements quality, including clarity, consistency, completeness, testability, and traceability.

Experience developing or maintaining system architecture, and interfaces across multidisciplinary engineering teams.

Strong DHF and design control experience, including documentation review, traceability, and remediation of gaps.

Experience maintaining end-to-end traceability across requirements, design outputs, risk controls, and verification evidence.

Strong analytical, documentation, communication, and cross-functional facilitation skills.

Willingness and ability to travel internationally.

Experience with Diagnostic Imaging Medical Devices or related imaging systems, preferred.

Work Arrangement

This is a hybrid consulting engagement, requiring a combination of on-site collaboration and remote work based on project needs and client expectations. The individual must be comfortable working independently, engaging directly with client engineering and quality leadership, and taking ownership of assigned remediation activities with minimal day-to-day direction.

Equal Opportunity Employer

We are committed to recruiting, developing, and retaining the most talented people from a diverse candidate pool. All aspects of employment, including the decision to hire or promote, will be based on aptitude, performance, and business need. We do not discriminate on the basis of race, color, religion, sex, national origin, age, physical or mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, or any other legally protected status. We will make reasonable accommodation for qualified individuals in accordance with applicable law.