Senior Manager, Components Engineering, R&D - MedTech

Johnson & Johnson • Cincinnati, OH

2d • Hybrid

About The Position

This role is for a Senior Manager, Components Engineering, R&D – MedTech to support Johnson & Johnson's handheld medical devices business. The position is located in Cincinnati, OH, and operates on a Flex/Hybrid schedule with 3 days per week on-site. The company's Surgery team develops surgical technologies and solutions, including surgical staplers, clip appliers, trocars, and sealing devices, used in minimally invasive and open surgical procedures. The Senior Manager will lead a newly formed Component Development Engineering Team for the Handheld Instrument business, focusing on people leadership, technical direction, capability building, execution excellence, and innovation. The role involves partnering closely with project, quality, manufacturing, supply chain, and clinical stakeholders to meet business objectives, with significant influence on reducing capital expenditure for component tooling/assembly equipment, expense spending, and improving component costing (COGS).

Requirements

• Bachelor’s degree in engineering (Mechanical, Electrical, Biomedical, Manufacturing, or related discipline) is required.
• Minimum of 8+ years of progressive engineering experience in component development activities across a wide variety of technologies such as metals, plastics and electro-mechanical components and sub-assemblies is required.
• Experience in validation activities such IQ/OQ /PQ or PPAP is required.
• Experience in component process development, characterization and validation in a regulated industry is required.
• Experience in general DF(X) - Design for Manufacturing, Molding, Assembly, etc. is required.
• Experience in Risk Management – PFMEAs, parallel pathing, dual sourcing strategies etc.
• Strong organizational and communication skills are required.
• Strong foundation in data analytics and statistical understanding is required.
• Demonstrated people leadership experience leading high performing engineering teams is required.
• Demonstrated ability to partner with internal and external suppliers to achieve outcomes.

Nice To Haves

• An advanced degree is preferred.
• Experience in cost engineering, supply chain management and materials management/development is preferred.
• Experience in medical device industries strongly preferred.
• Experience in new materials development strongly preferred.
• Six Sigma Certification (DMAIIC) strongly preferred.
• Direct experience working in manufacturing is strongly preferred.

Responsibilities

• Serve as the functional manager for Component Development Engineering Team, providing technical leadership and oversight across manufacturing engineering disciplines such as Injection Molding, Extrusion, Machining, Metal Injection Molding, Stamping, PCBAs, Electro Mechanical Fabrication and light assembly.
• Establish and reinforce engineering best practices, standards, and development methodologies related to development of medical device components and associated validation activities such as IQ/OQ/PQ, Gage R&Rs, Control Plans, PMFEAs, Process Characterization (DOEs) and Process Capability (Ppk / Cpk).
• Provide technical guidance and problem-solving support for complex 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 8–12 full time engineers and up to 5 contractors.
• Conduct performance management, goal setting, coaching, and 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 innovative & technical solutions and leverage external partnerships to advance technology for our materials of construction and 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 the “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
• 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: Senior