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Johnson & Johnson

Senior Systems Engineer – Nav R&D

Johnson & Johnson

. Author, decompose and maintain system and subsystem requirements for assigned features .

Posted 10/23/2026full-timeBoston • Massachusetts • United StatesSenior💰 $109,000 - $174,800 per yearWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in systems engineering for medical devices, including requirements management, risk analysis, and compliance with regulatory standards such as IEC 60601 and ISO 14971. Proficient in cross-functional collaboration and technical communication to support system integration and design processes.

Highest-signal resume keywords
Systems Engineering ExperienceRequirements ManagementRisk ManagementRegulatory ComplianceTechnical Writing

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Requirements DecompositionSystem-Level Risk AnalysisFMEAUse Case DevelopmentInterface ManagementIntegration TestingDesign ControlsSystem ArchitectureVerification and ValidationSustaining Engineering
Soft Skills
Cross-Functional CollaborationCommunicationMentoring
Tools & Technologies
PolarionJamaDOORS
Industry Keywords
Medical DevicesRegulated IndustryIEC 60601ISO 14971ISO 13485IEC 62366

About the role

Key responsibilities & impact
  • Author, decompose and maintain system and subsystem requirements for assigned features
  • Keep requirements structured, traceable and communicated across multi-site teams
  • Perform system-level risk analysis, including hazard analysis, use risk analysis and FMEA
  • Support risk cascade to subsystem teams
  • Ensure requirements are testable and fully traced from user needs through verification and validation
  • Develop use cases, user stories and workflows with clinical, marketing and human factors partners
  • Define and analyze mechanical, electrical and software interfaces
  • Support system integration, integration testing and issue resolution
  • Contribute to system architecture, functional diagrams and design trade-off studies
  • Support design reviews, change impact assessments and sustaining engineering for released products
  • Support regulatory submissions and DHF deliverables
  • Ensure system deliverables meet IEC 60601, ISO 14971 and IEC 62366 requirements
  • Engage with surgeons and clinical staff in lab and OR settings
  • Mentor junior engineers and co-ops on systems engineering methods and tools
  • Communicate business-related issues or opportunities to the next management level
  • Follow Company guidelines on Health, Safety and Environmental practices and applicable regulations

Requirements

What you’ll need
  • Bachelor's degree in Systems, Biomedical, Electrical, Mechanical, Robotics or Mechatronics Engineering, or a related field
  • 5+ years of relevant systems engineering experience in medical devices or another regulated industry
  • Experience with Design Controls, requirements management and risk management in a regulated environment
  • Experience with an ALM/requirements tool such as Polarion, Jama or DOORS
  • Working knowledge of IEC 60601, ISO 14971, ISO 13485 and IEC 62366
  • Experience with system integration and interface management across software, electrical and mechanical subsystems
  • Strong technical writing, communication and cross-functional collaboration skills

Benefits

Comp & perks
  • Retirement plan (pension)
  • Savings plan (401(k))
  • Long-term incentive program
  • Vacation – 120 hours per calendar year
  • Sick time – 40 hours per calendar year; 48 hours per calendar year for employees residing in Colorado; 56 hours per calendar year for employees residing in Washington
  • Holiday pay, including Floating Holidays – 13 days per calendar year
  • Work, Personal and Family Time – up to 40 hours per calendar year
  • Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
  • Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
  • Caregiver Leave – 80 hours in a 52-week rolling period
  • Volunteer Leave – 32 hours per calendar year
  • Military Spouse Time-Off – 80 hours per calendar year
  • Hybrid work arrangement
  • Travel opportunities up to 10% domestic and/or international