Senior Manager, Design Systems - MedTech Surgery

Johnson & Johnson•Cincinnati, OH

2d•Hybrid

About The Position

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 About Surgery Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech We are searching for the best talent for a Senior Manager, Design Systems. This role will located in Cincinnati, OH & work a Flex/Hybrid schedule with 3 days per week on-site. Relocation assistance is available to qualified candidates. Purpose: Our Senior Manager will have end to end ownership over our system requirements, risk management, test methods, and Verification and Validation strategies for the Hand-held devices. The role will also have responsibility to develop and mature Systems Engineering principles, tools, and process. 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, and oversight responsibilities for executing against all of our risk mitigation and design control deliverables.

Requirements

Minimum of a Bachelor's degree is required, Advanced Degree strongly preferred.
Engineering or Science discipline highly desired.
Minimum 12+ years of relevant work experience required.
At least 2+ years relevant experience as a people leader with 5 or more direct reports required.
Experience or certification in Systems Engineering principles including -Model or similar framework.
Proficient in lean and six sigma methodologies.
Proven track record leading product development teams to deliver R&D goals and milestones.
Strong communication, interpersonal skills, and an ability to work effectively with teams.
Expertise in building requirements and the associated traceability of requirements through-out the design controls deliverables.
Expertise around risk management and documentation (e.g. FMEA’s).
Expertise in designing complex design verification and validation strategies.
Expertise in Test Method Validations and Measurement Systems Analysis (e.g. Gage R&R’s).
Requires up to 10% domestic and international travel.

Nice To Haves

Medical Device industry experience or regulated industry experience are a plus for this role.
Understanding of surgery, surgical procedures, and the design and application of surgical devices, as well as the quality system / regulatory environment is preferred.

Responsibilities

Provide overall technical oversight and leadership for Design Systems and Execution Team.
Establish departmental standards for software, techniques, and tools for systems engineering, product requirements-traceability, and FMEA’s.
Develop and lead a best-in-class Test Method Validation and Measure System Analysis group.
Establish the groups’ guidelines, standards and adherence to our verification and validation strategies.
Ability to use analytical skills to assess and modify design proposals to mitigate any potential failures or flaw.
Proactively assess and review risk mitigation and escalation processes and drive timely project execution.
Develop metrics, scorecards, and communicate program progress with the organization, partners, and senior leadership.
Collaborate, cooperate, and coordinate with cross-functional partners.
Partner with R&D platform leadership to support success of platform goals and objectives.
Ensure projects are delivered according to scope, schedule, budget, and quality baselines.
Develop talent, across multiple levels, through effective coaching, 1:1’s, mentoring and candid feedback.

Benefits

employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year