Johnson & Johnson MedTech · 1 day ago
Sr Systems Engineer, Abiomed
Danvers, MA
Full-time
Onsite
Mid, Senior Level
$109K/yr - $196K/yr
5+ years expJohnson & Johnson is a leader in healthcare innovation, and they are seeking a Senior Systems Engineer to join their Cardiovascular team at Abiomed. This role involves owning design input requirements and providing technical leadership across multi-disciplinary projects for advanced medical devices.
Hospital & Health Care
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
Qualification
Required
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
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
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Company’s consolidated retirement plan (pension)
Savings plan (401(k))
Company’s 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
Company
Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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