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Senior Systems Engineer - 2406191574W

Description

Johnson & Johnson is currently seeking a Senior Systems Engineer to join our preCARDIA Engineering Team based in Danvers, MA.

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. Learn more at https://www.jnj.com/ (https://url.us.m.mimecastprotect.com/s/MR_SCqxD2Oivo14wsZygBQ?domain=jnj.com/) .

Responsibilities

• Use technical expertise, knowledge, and experience to rapidly innovate the companies’ medical devices for use in chronic heart failure patients.

• Lead the creation and conversion of user needs into design inputs, develop test plans, and create risk documentation (dFMEA, etc)

• Plan, conduct, and analyze system-level tests across our development roadmap of preCARDIA devices.

• Write validation protocols and support user validation

• Lead bench and animal testing to simulate current clinical feedback from the field. At the same time, bring a systems integration mindset and those learnings into future product development to lead the creation of next gen requirements and the path to verification.

• Evaluate and analyze device performance data utilizing technical and clinical knowledge to drive technical understanding and data-driven improvement plans.

• Fabricate and evaluate prototypes with assistance from junior staff, technical support team (Machine Shop, Technicians and Designers) and suppliers.

• Perform literature reviews, engage with physician, and heart failure care professionals, and develop quantitative analyses to unique problem sets spanning materials science, systems thinking, mechanical design, and biomechanical dynamics.

• Evaluate end user needs, standards requirements, and risk evaluations to generate design requirements and engineering targets which include design for manufacturing, assembly, and automation.

• Contribute to, author, and manage design history file documents – for example requirement, risk management, and test report documents.

• Develop and prepare test protocols, reports, and engineering summaries with expertise in technical writing capabilities.

• Prepare and deliver PPT presentations of technical design reviews to cross-functional team members.

Qualifications

• 6 years product development experience; strong preference for experience with class III medical device development

• BS in Mechanical, Electromechanical, or Biomedical Engineering required; advanced degree in related discipline preferred.

• Ability to travel up to 10% of the time, domestically & international (US & EU)

• Experience spending time in clinical environment preferred (i.e. OR, ICU, engaging with heart failure and/or cardiac physicians).

• Ability to work in cross-functional teams that span global operations. Proficient in English verbal and written communication.

• Must enjoy team approach over individual contributions.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

Primary Location NA-US-4887-Danvers

Organization ABIOMED Inc.(6942)

Job Function Biomedical Engineering

Req ID: 2406191574W