Johnson & Johnson MedTech
Sr Systems Engineer, Abiomed
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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.
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
Overview 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.
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
Equal Opportunity Employer 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, 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.
Pay Transparency US: $109,000 - $196,000
Benefits Employees are eligible to participate in the Company’s consolidated retirement plan (401(k)) and a long‑term incentive program. Eligible contractors receive coverage under the Company’s health, dental, vision, life insurance, short‑term and long‑term disability, and business accident insurance plans. Additional benefits include vacation, sick time, holiday pay, work‑personal and family time, parental leave, condolence leave, caregiver leave, volunteer leave, and military spouse time‑off. Refer to
https://www.careers.jnj.com/employee-benefits
for detailed information.
#J-18808-Ljbffr
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.
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
Overview 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.
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
Equal Opportunity Employer 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, 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.
Pay Transparency US: $109,000 - $196,000
Benefits Employees are eligible to participate in the Company’s consolidated retirement plan (401(k)) and a long‑term incentive program. Eligible contractors receive coverage under the Company’s health, dental, vision, life insurance, short‑term and long‑term disability, and business accident insurance plans. Additional benefits include vacation, sick time, holiday pay, work‑personal and family time, parental leave, condolence leave, caregiver leave, volunteer leave, and military spouse time‑off. Refer to
https://www.careers.jnj.com/employee-benefits
for detailed information.
#J-18808-Ljbffr