Senior Systems Engineer

Jobtailor; Acton (MA); On-site; USD 120,000 - 160,000; Full time

Job summary

Jobtailor is seeking a Systems Engineer to drive system-level design and regulatory compliance for medical devices. You will work with electrical, software, mechanical, manufacturing, and quality engineers to ensure safe, effective products.

Responsibilities include risk management per ISO 14971, design history file preparation, and cross-functional collaboration across global teams. Strong regulatory knowledge and test plan development are essential.

Qualifications

• Bachelor's degree in engineering or related field.
• 4+ years in medical device or highly regulated product development.
• 6+ years in systems engineering within product development.
• Experience with requirements management software (Jama, Polarion, Doors).
• Experience with systems verification/validation and test method development.

Responsibilities

• Serve as a key member of cross-functional project teams across engineering disciplines.
• Drive requirements refinement, risk reviews, mitigations, and verification plans.
• Perform functional and trade-off analyses to drive design improvements.
• Troubleshoot system-level issues and perform root cause analysis.
• Lead risk management activities per ISO 14971 throughout the lifecycle.
• Ensure regulatory compliance including FDA QSR 21 CFR 820, ISO 13485, IEC 60601.
• Prepare DHF and technical documentation for regulatory submissions.
• Support external regulatory audits by FDA or Notified Bodies.
• Develop and execute test plans, protocols, and reports for integration, verification, validation.
• Provide technical support for post-market surveillance and improvements.
• Analyze customer complaints and field issues via risk assessments and investigations.
• Manage device and manufacturing process changes and risk file maintenance.
• Guide peers and teams on systems engineering processes and tools.

Skills

System-level design

Requirements management

Architectural development

Analytical thinking

Problem-solving

Communication skills

Cross-functional collaboration

Regulatory documentation

Education

Bachelor's degree in Engineering or related field

Tools

Jama

Polarion

Doors

Job description

• Serve as a key member of a cross-functional project team consisting of electrical, software, mechanical, manufacturing, and quality engineers to achieve project deliverables.
• Serve as a system technical expert for design changes to subsystems by driving requirement refinement, performing risk reviews, implementing risk mitigations, and developing system verification plans to verify the design change.
• Perform functional analysis, timeline analysis, and detailed trade-off studies to drive design improvements and cost-reduction to existing subsystems.
• Troubleshoot system-level issues, perform root cause analysis, and implement effective solutions throughout the development process.
• Lead risk management activities, including hazard identification and Failure Modes and Effects Analysis (FMEA), throughout the product lifecycle in accordance with ISO 14971.
• Ensure that all design and development activities comply with regulatory requirements, including FDA Quality System Regulation (QSR) 21 CFR Part 820, ISO 13485, and IEC 60601.
• Work closely with regulatory affairs and quality assurance teams to prepare and maintain the Design History File (DHF) and other technical documentation for regulatory submissions.
• Support external audits conducted by regulatory bodies such as the FDA or Notified Bodies.
• Develop, author, and execute comprehensive test plans, protocols, and reports for system integration, verification, and validation.
• Provide technical support and expertise to cross-functional teams for post-market surveillance and continuous improvement activities.
• Analyze and address customer complaints and field issues through risk assessments and technical investigations.
• Manage device and manufacturing process changes, including documentation updates and risk file maintenance.
• Guide and offer expertise with peers, providing guidance on systems engineering processes and tools.

Requirements

• Bachelor of Science required (preferred field of study in: Engineering, Biomedical, Electrical, Mechanical, Systems)
• 4+ years of experience working in the medical device industry / highly regulated product development industry
• 6+ years of experience working directly in a Systems Engineering discipline within product development.
• Proficiency in system-level design, requirements management, and architectural development.
• Solid understanding of medical device regulations (FDA QSR, ISO 13485) and risk management (ISO 14971).
• Experience with requirements management software (e.g., Jama, Polarion, Doors) is required.
• Experience with systems verification/validation, including test method development.
• Strong analytical and problem-solving abilities.
• Excellent written and verbal communication skills.
• Demonstrated ability to collaborate effectively with cross-functional and global teams.
• Strong organizational skills and attention to detail, particularly for regulatory documentation.
• Creative out-of-the box thinker who can devise new approaches and processes that meet regulatory needs but adaptive to address business and market needs.

Core Competencies

Demonstrates expertise in Systems Engineering within the medical device industry, focusing on regulatory compliance, risk management, and system-level design. Proficient in developing and executing test plans, managing requirements, and collaborating with cross-functional teams to ensure product quality and safety.