Sr Systems Engineer, Abiomed

Sr Systems Engineer, Abiomed

Join to apply for the Sr Systems Engineer, Abiomed role at Johnson & Johnson Med Tech.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.

Job Function
: R&D Product Development
Job Sub Function
: R&D Software/Systems Engineering
Job Category
:
Scientific/Technology
Location
:
Danvers, Massachusetts, United States of America

As a Senior Systems Engineer, you will own the design input requirements and provide technical leadership across multidisciplinary projects for advanced medical devices. You will lead design verification activities in preparation for regulatory submissions and work closely with electrical, mechanical, software, and clinical engineers while collaborating with cross-functional partners in Quality, Regulatory, Manufacturing, and Supply Chain. You will translate system-level requirements into verifiable designs, drive test strategy and execution, and ensure traceability from requirements through verification and reporting.

• Lead ownership of system design inputs and requirements: define, decompose, maintain traceability, and ensure alignment across disciplines.
• Provide technical leadership and mentorship for cross‑functional engineering teams (electrical, mechanical, software, clinical).
• Define verification strategy and acceptance criteria derived from design inputs, risk analyses, and regulatory requirements.
• Author, review, and approve verification and validation (V&V) test plans, protocols, procedures, and reports.
• Plan and execute Design Verification Testing (DVT) including extended reliability and environmental tests; ensure test setups meet applicable standards.
• Develop and validate test instrumentation, fixtures, and data acquisition systems needed for verification activities.
• Perform hands‑on test execution and troubleshooting; train and guide technicians and engineers on test procedures and best practices.
• Analyze test data using statistical methods; summarize results and provide actionable technical conclusions.
• Coordinate with Quality and Regulatory to prepare verification packages for regulatory submissions; ensure traceability and completeness of documentation.
• Contribute to design failure investigations and supplier/manufacturing issues that may impact Risk Assessment, Hazard Analysis, and Fault Tree Analyses.
• Manage requirements in a requirements‑management tool and maintain traceability between requirements, design, and verification artifacts.
• Communicate technical status, risks, and milestones to project leadership and stakeholders; act as a technical point of contact for verification‑related matters.

• BS or MS in Electrical, Mechanical, Software, Biomedical Engineering, or a related engineering discipline.
• Minimum of 5 years of experience in medical device development (senior‑level candidates often have more).
• Demonstrated experience owning requirements and verification activities for complex electro‑mechanical or embedded medical devices.
• Hands‑on experience with test instrumentation and data acquisition (oscilloscopes, multimeters, function generators, power supplies, pressure/flow/temperature transducers).
• Proven ability to create and execute test plans, protocols, and reports; strong familiarity with design controls and traceability practices.
• Solid understanding of medical device regulatory environment and standards (for example, IEC 60601‑1 and applicable FDA guidance).
• Experience with communication interfaces and embedded systems (UART, USB, CAN) and embedded device testing.
• Proficiency with data analysis tools (Matlab) and basic scripting/programming skills (Python); experience with LabVIEW or similar DAQ programming tools is strongly preferred.
• Strong analytical and…