Senior Manager, Components Engineering, R&d - Medtech

Johnson & Johnson Johnson & Johnson · Pharma · Cincinnati, OH +1

Senior Manager, Components Engineering, R&D – MedTech to support handheld medical devices business. This role will be located in Cincinnati, OH & work a Flex/Hybrid schedule with 3 days per week on-site. The Senior Manager, Components Engineering, R&D, will lead a to lead a newly formed Component Development Engineering Team for its Handheld Instrument business. In this role, the candidate will perform as a functional people leader; responsible for building, leading, and sustaining a high-performing component 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 have 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 and expense spending and improved component costing (COGS).

What you'd actually do

  1. 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.
  2. 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).
  3. Provide technical guidance and problem-solving support for complex development challenges for the business.
  4. Act as a technical escalation point for development issues impacting financials, quality, safety, or performance.
  5. Lead, coach, and develop a team of 8–12 full time engineers and up to 5 contractors.

Skills

Required

  • Bachelor’s degree in engineering (Mechanical, Electrical, Biomedical, Manufacturing)
  • Experience in leading engineering teams
  • Experience in medical device components development
  • Experience in manufacturing engineering disciplines (Injection Molding, Extrusion, Machining, Metal Injection Molding, Stamping, PCBAs, Electro Mechanical Fabrication)
  • Knowledge of engineering best practices, standards, and development methodologies
  • Experience with validation activities (IQ/OQ/PQ, Gage R&Rs, Control Plans, PMFEAs, Process Characterization, Process Capability)
  • Problem-solving skills
  • Risk management (FMEA)
  • Statistical analysis

Nice to have

  • Experience with modeling and simulation techniques
  • Experience with Design to Value principles

What the JD emphasized

  • functional people leader
  • people leadership
  • technical direction
  • capability building
  • execution excellence
  • innovation
  • technical experience
  • partnering closely with project, quality, manufacturing, supply chain, and clinical stakeholders
  • reduced capex for component tooling / assembly equipment and expense spending
  • improved component costing (COGS)
  • engineering best practices, standards, and development methodologies
  • validation activities such as IQ/OQ/PQ, Gage R&Rs, Control Plans, PMFEAs, Process Characterization (DOEs) and Process Capability (Ppk / Cpk)
  • technical guidance and problem-solving support for complex development challenges
  • 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.
  • 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.