Sr Systems Engineer, Abiomed

Sr Systems Engineer – Abiomed

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 MedTech, 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.

Johnson & Johnson is hiring for a Senior 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.

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.

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.

Key Responsibilities

• 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.

Required Qualifications

• 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 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.

Preferred Qualifications

• 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.

Core Competencies

• Systems thinking and requirements decomposition
• Verification & validation strategy and execution
• Test automation and data acquisition
• Risk-based decision making
• Cross-functional collaboration and stakeholder management
• Technical writing and documentation discipline
• Problem solving and root-cause analysis

Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. Abiomed maintains a drug-free workplace. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

Required Skills: Accountability, Data Analysis, Innovation, Laboratory Experiments, Product Development

Preferred Skills: Agility Jumps, Analytical Reasoning, Coaching, Collaborating, Critical Thinking, Model-Based Systems Engineering (MBSE), Product Design, Report Writing, Requirements Analysis, Research and Development, SAP Product Lifecycle Management, Scripting Languages, Software Architectures, Software Development Management, Software Engineering Practices, Software Quality Assurance (SQA), Systems Development Lifecycle (SDLC), Technologically Savvy

The anticipated base pay range for this position is: US: $109,000 - $196,000. Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: 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 –