Principal Engineer, Performance Evaluation - 2406171204WDescriptionEthicon Inc, part of Johnson & Johnson MedTech is recruiting for a Principal Engineer, Performance Evaluation located in Raritan, NJ.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/ .Overall ResponsibilitiesA position is available in the Performance Evaluation Group of R&D and may include some or all of the following responsibilities:
Provide technical leadership and characterization strategies to project teams from feasibility to launch in the area of physical and mechanical testing for wound closure, biosurgery and plastic surgery biomaterials and related devices.
Develop clinically relevant screening mechanical benchtop test models for materials and devices for properties such as tensile, compression, torque, burst and flexibility. Partner with preclinical research to enable correlations between benchtop and preclinical models.
Assist with compliance efforts of the group including leading laboratory investigation reports for data not meeting criteria, supporting internal and external audits including subsequent investigations for any findings and support of all GMP related lab issues.
Subject matter expert for physical test method and equipment validation and also assist with identification and procurement of state of the art new test equipment for characterization of mechanical and physical properties of materials and medical devices.
Liaison with manufacturing plants including support of test method validations, audit support and troubleshooting for testing issues.
Collaborate with various project team members such as preclinical, regulatory, team leads, marketing, quality engineers and operations.
Supervise and guide development of several engineers.
QualificationsEducation:
A minimum of Bachelor's Degree in Mechanical Engineering, Biomedical Engineering, Materials Science and Engineering or related field; an advanced degree (MS/PhD is preferred).
Required Skills & Experience:
A minimum of 8 years experience in a laboratory environment and must be willing to perform hands-on experiments and be able to clearly communicate findings to the project team.
Must be able to work/test in a regulated medical device environment (cGMP) and able to interact with internal and external auditors.
Must have knowledge of design control/regulations for medical devices and/or combination products (national and international requirements)
Previous experience working with harvested animal tissue and knowledge of anatomy and physiology for humans and animals.
Experience running mechanical testing equipment such as Instron materials testers (or equivalent) and ability to design test fixture drawings in Solidworks
Investigation skills required for testing failures and root cause analysis for input into non-conformance software system (NCs and CAPAs)
Strong statistical knowledge as demonstrated through use of Minitab or equivalent software for test method validation and data analysis.
Other:
This position is based in Raritan, NJ and requires up to 10% domestic/international travel.
The anticipated base pay range for this position is [$106,000] to [$191,000].The anticipated time period this position will be posted is 3/11-3/16.The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below.Eligible for benefits to include medical, dental, vision and time off as well as any others as provided for in the applicable Collective Bargaining Agreement.For additional general information on company benefits, please go to: - https://www.careers.jnj.com/employee-benefitsJohnson & 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.Primary Location NA-US-New Jersey-RaritanOrganization Ethicon Inc. (6045)Job Function R&D Mechanical EngineeringReq ID: 2406171204W
