Sr Systems Engineer, Abiomed

Johnson & Johnson-posted 20 days ago

Full-time • Mid Level

Danvers, MA

5,001-10,000 employees

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Johnson & Johnson is hiring for a Sr Systems Engineer – Abiomed to join our team located in Danvers, Massachusetts. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech ABOUT US: Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity, and innovation. Patients First | Innovation | Winning Culture | Heart Recovery Overview As a Senior Systems Engineer, you will own the design input requirements and provide technical leadership across multi-disciplinary 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 60601-1IEC 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 statistical skills for interpreting test results.
Excellent written and verbal communication skills and the ability to work effectively in cross-functional teams.
Ability to work independently, take ownership of tasks, and drive results in a project environment.

MS degree in a relevant engineering field.
Prior experience with JAMA or similar requirements-management software.
Experience with risk management tools and methodologies (FMEA, FTA).
Experience supporting regulatory submissions and preparing verification packages for FDA/Notified Body review.
Experience with complex fluidic systems and electro-mechanical integration.
Experience in mentoring and technical leadership roles.

medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Company’s consolidated retirement plan (pension) and savings plan (401(k)).
long-term incentive program.
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
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
Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave – 10 days
Volunteer Leave – 4 days
Military Spouse Time-Off – 80 hours

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