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JOB DESCRIPTION:

We are searching for the best talent to join our MedTech Surgery team as a Primary Designer Engineer, located in Cincinnati, OH.
Purpose: The R&D Design Systems and Execution (DS&E) Primary Design Engineer will focus on the Design Systems, Verification and Validation pillars of the DS&E team. They will work to develop and execute against the strategies for System Requirements (requirements workbook), Risk Management, Test Method Validations and Verification methods for Handheld devices. This role will support the delivery of future innovations needed to change the standard of care in general surgery. The Primary Engineer should be able to collaborate with the immediate team to challenge the status quo and usher in better and faster ways of delivering products.

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Develop and execute against departmental standards for techniques and tools for product and system requirements and FMEA’s
• Develop and execute against the groups’ guidelines, standards and adherence to our verification and validation strategies
• Develop customer requirements and product specifications with validated test methods for design verification and product claims testing.
• Develop and execute against design verification protocols, including testing, data analysis, report generation
• Support the development of the DFMEA for future products
• Support the design of new or existing components and/or devices while ensuring that all design requirements are met
• Use of analytical skills to assess and modify design proposals to mitigate any potential design related risks
• Proactively assess and review risk mitigation and escalation processes and drive timely project execution
• Collaborate, cooperate, and coordinate with cross-functional partners

Education and Required Experience:

• A minimum of a bachelor’s degree in mechanical engineering or a related science/engineering degree
• A minimum of 2 years of relevant work experience
• Proficiency around risk management and documentation (e.g. FMEA’s)
• Proficiency in building requirements and the associated traceability of requirements throughout the Design Controls deliverables
• Proficiency in designing complex Design Verification and Validation strategies
• Proficiency in Test Method Validations (TMV) and Measurement Systems Analysis (e.g., Gage R&Rs)
• Ability to apply analytical skills within the R&D development process to drive complex projects to completion
• Strong mechanical design and analysis skills, including an understanding of mechanical subsystem functionality and integration
• Strong communication and interpersonal skills; an ability to work effectively with teams

Preferred Skills & Experiences:

• Experience in designing, developing, and launching products within an FDA-regulated environment is preferred (e.g. Medical, Automotive)
• Understanding of surgery, surgical procedures, and the design and application of surgical devices, as well as the quality system / regulatory environment
• Experience building prototypes, products, and systems for testing; along with setting up and running laboratory simulations
• Experience designing test procedures, coordinating tests, analyzing results, and developing written reports
• Experience conducting and/or participating in technical design reviews of requirements, specifications, designs, etc.
• Strong understanding of design control; the ability to develop and execute design plans, design verification and validation

Other:

• This position is based in Cincinnati, OH and requires up to 10% travel

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 and 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 email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
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 and 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 email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource

Please refer the Job description for details