Manager, Applications Engineering, R&D - MedTech

Johnson & Johnson Innovative Medicine • Cincinnati, OH

1d • 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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: R&D Product Development Job Sub Function: R&D Mechanical Engineering Job Category: People Leader All Job Posting Locations: Cincinnati, Ohio, United States of America Job Description: 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 Manager, Applications Engineering, R&D – MedTech to support our handheld medical devices business. This role is located in Cincinnati, OH & will work a Flex/Hybrid schedule with 3 days per week on-site. Our business offers a broad range of products and technologies, including surgical staplers, clip appliers, trocars and sealing devices—that are used in a wide variety of minimally invasive and open surgical procedures. Purpose: The Manager, Applications Engineering, R&D, will lead a newly formed Application Development Engineering Team for its Handheld Instrument business. This team is focused on creating and validating right-sized, robust and reliable manufacturing processes that meet business objectives. In this role, the candidate will perform as a functional people leader; responsible for building, leading, and sustaining a high-performing application / process development engineering organization. This position focuses on people leadership, technical direction, capability building, execution excellence and innovation across multiple development engineering disciplines. To be successful in this role, the candidate will need to leverage their significant related technical experience while partnering closely with project, quality, manufacturing, supply chain, and clinical stakeholders to ensure business objectives are met. The role does not have direct capital expenditure or budget ownership but will have a heavy influence on delivering business objectives of reduced capex for component tooling / assembly equipment, expense spending and improved cost of conversion (COGS) of our products.

Requirements

• Bachelor’s degree in engineering (Mechanical, Electrical, Biomedical, Manufacturing, or related discipline) is required.
• Minimum of 6+ years of progressive engineering experience across design or manufacturing engineering disciplines is required.
• Experienced in manufacturing / assembly application development activities across a wide variety of process modalities is required.
• Experienced in general process development, characterization and validation in a regulated industry is required.
• Experienced in general DF(X) - Design for Manufacturing, Assembly, Cost etc. is required.
• Demonstrated ability to identify Risk Management – PFMEAs, parallel pathing, dual sourcing strategies etc. is required.
• Strong organizational and communication skills required.
• Strong foundation in data analytics and statistical understanding required.
• Demonstrated ability to partner with internal partners and external suppliers to achieve outcomes

Nice To Haves

• An advanced degree is preferred.
• Preferred experiences include chemical handling and processing, thermal processing (welding, heat staking, lamination etc.), coating technologies and general mechanical applications (crimping, pressing, cutting etc).
• Experience in medical device industries preferred.
• Six Sigma Certification (DMAIIC) strongly preferred.
• Direct experience working in manufacturing is strongly preferred.

Responsibilities

• Serve as the functional manager for the Application Development Engineering Team, providing technical leadership and oversight across a diverse set of manufacturing and assembly techniques.
• Establish and reinforce engineering best practices, standards, and development methodologies related to scale up of medical device manufacturing processes.
• Drive technical excellence and efficiency with associated validation activities such as IQ/OQ/PQ, Gage R&Rs, Control Plans, PMFEAs, Process Characterization (DOEs) and Process Capability analysis (Ppk/Cpk).
• Provide technical guidance, creative strategies and problem-solving support for complex application development challenges for the business.
• Act as a technical escalation point for development issues impacting financials, quality, safety, or performance.
• Lead, coach, and develop a team of 6-10 full-time engineers and up to 5 contractors.
• Conduct performance management, goal setting, coaching, career development planning.
• Identify skill gaps and drive development through mentoring, training, and hiring as needed.
• Build functional communities of practice and subject matter expertise.
• Partner with the broader J&J Surgery organization to leverage synergies and drive efficiencies.
• Partner with Leaders cross functionally to identify and fulfill resource needs to deliver on business priorities and commitments across NPD Projects.
• Provide resourcing input, risk identification and prioritization recommendations as needed.
• Ensure engineering deliverables meet device performance, quality, financial and regulatory requirements.
• Oversee all NPD development activities for the function including design reviews, risk management (FMEA), verification / validation support, engineering testing strategies, and statistical analysis.
• Ensure team compliance with design controls and quality / regulatory system requirements.
• Drive continuous improvement in engineering execution and documentation quality.
• Develop learning plans and demonstrate process feasibility through proof of principal and / or pilot scale processes prior to scaling for production.
• Develop innovative & technical solutions and leverage external partnerships to advance technology for our manufacturing processes.
• Accelerate and improve team outcomes by leveraging and deploying modeling and simulation techniques across the function.
• Implement “Design to Value” principals across team to reduce the gap between current cost of goods sold (COGS) and should cost target for new product projects.

Benefits

• 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
• 10 days Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Manager