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Director Engineering- New Product Development

Director of Engineering- New Product Development


Location: San Diego, CA (Onsite)

Relocation Assistance Available


Overview

A leading global medical technology organization is seeking a senior engineering/R&D leader to drive complex product development initiatives within a high-impact device portfolio.


This role is responsible for leading enterprise-level development programs spanning hardware, software, and systems integration. You will serve as the central business and execution owner for new product initiatives, ensuring strategic alignment, operational excellence, and predictable commercial delivery.


This is not a traditional project management role; this is a cross-functional business leadership position with full accountability for results.


Key Responsibilities

Enterprise Program Leadership

  • Direct end-to-end development of complex, regulated medical device programs from concept through commercial launch
  • Lead cross-functional teams across R&D, Regulatory, Quality, Operations, Marketing, and Service
  • Ensure execution aligns with portfolio strategy, revenue targets, and long-term platform growth


Strategic & Business Alignment

  • Translate corporate objectives into executable development roadmaps
  • Drive prioritization and trade-off decisions to protect timelines and business value
  • Present program status, risk posture, and strategic updates to executive leadership


Execution & Operational Excellence

  • Establish integrated program plans, milestones, and measurable success criteria
  • Manage budget forecasting and resource planning
  • Oversee risk management frameworks, mitigation planning, and escalation pathways
  • Ensure readiness for design transfer, manufacturing scale-up, and commercial release


Organizational Impact

  • Build high-performing, accountable cross-functional teams
  • Remove roadblocks and accelerate decision-making
  • Mentor emerging leaders across technical and functional groups
  • Champion continuous improvement in product development processes


Qualifications

Required

  • Bachelor’s degree in Engineering or a scientific discipline
  • 9+ years of experience in medical device product development or another highly regulated industry
  • 5+ years leading complex, cross-functional teams
  • Proven track record delivering successful new product launches
  • Strong understanding of design controls, quality systems, and regulatory frameworks (FDA experience preferred)
  • Experience with design transfer and manufacturing readiness


Preferred

  • Advanced degree (MS or PhD)
  • Experience leading hardware/software integrated systems programs
  • Background in capital equipment or connected medical technologies

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