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Ethicon, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Manager for Design Systems and Execution located in Cincinnati, OH.
Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com .
Our Senior Manager will have ownership over our risk management, system requirements (requirements work-book), Test Method Validations, and Verification and Validation strategies for the Hand-held devices. This role will support the delivery of future innovations needed to change the standard of care in general surgery. The leader should have a change agent mindset to usher the organization towards cutting edge, lean, ‘quality appropriate to the task’ methodologies while appreciating the legacy procedures that drove our previous success.
The role will serve the full Endo-mechanical and Energy portfolios and work closely with the NPD and PPMG Sponsors to balance resources in accordance to priority and need. Further, the leader will partner with the Quality and Regulatory groups to ensure we are maintaining the highest level of compliance that has been a staple within Ethicon. This team member will have career development, resource management, budget, and oversight responsibilities for executing against all of our risk mitigation and design control deliverables.
Key Responsibilities:
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Establish departmental standards for software, techniques, and tools for product and system requirements-traceability and FMEA’s
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Develop and lead a best-in-class Test Method Validation and Measure System Analysis group
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Establish the groups’ guidelines, standards and adherence to our verification and validation strategies
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Ability to use analytical skills to assess and modify design proposals to mitigate any potential failures or flaw
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Proactively assess and review risk mitigation and escalation processes and drive timely project execution
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Communicate effectively with various levels in the organization
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Collaborate, cooperate, and coordinate with cross-functional partners
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Partner with R&D platform leadership to support success of platform goals and objectives
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Ensure projects are delivered according to scope, schedule, budget, and quality baselines
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Develop talent, across multiple levels, through effective coaching, 1:1’s, mentoring and candid feedback
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Qualifications:
Education:
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Minimum Bachelor's degree in engineering, advanced degree preferred
Required:
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Minimum 8 years of relevant work experience
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Expertise around risk management and documentation (e.g. FMEA’s)
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Expertise in building requirements and the associated traceability of requirements through-out the design controls deliverables
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Expertise in designing complex design verification and validation strategies
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Expertise in Test Method Validations and Measurement Systems Analysis (e.g. Gage R&R’s)
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Proficient in lean and six sigma methodologies
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Ability to apply analytical skills within the R&D development process to drive complex projects to completion
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Experience with product development in a regulated industry (e.g. medical, automotive)
Preferred:
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Strong communication and interpersonal and skills and an ability to work effectively with teams
Other:
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Requires up to 5% domestic and international travel
At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.
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 .
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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.