Senior Principal Engineer, Medical Device Tech Program Lead

W. L. Gore & Associates, Inc.

Phoenix (AZ)

Hybrid

USD 150,000 - 210,000

Full time

14 days+
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Benefits offered by this job

Stock Ownership Plan
Profit-sharing
Hybrid work arrangement

Job summary

Gore Medical in the United States is seeking a Senior Principal Engineer - Technical Program Leader to own the technical direction and delivery of a new product development program for a complex medical device.

The role combines hands-on engineering leadership with end-to-end accountability from concept through commercialization, partnering with engineering, manufacturing, clinical, quality and regulatory teams.

Qualifications

  • Bachelor's degree in Engineering.
  • 8+ years in medical device commercial support or NPD.
  • Experience leading cross-functional NPD programs.
  • Experience with design controls per ISO 13485/14971.
  • Strong communication, analytics, and collaboration skills.

Responsibilities

  • Define and deliver program technical strategies aligned with business goals.
  • Own architecture decisions, trade-offs, and technical direction.
  • Lead NPD execution across the full product lifecycle.
  • Oversee system integration and cross-functional alignment.
  • Identify and mitigate technical risks including FMEA/hazard analysis.
  • Collaborate with manufacturing, quality, regulatory, clinical, supply chain.
  • Engage external partners and drive IP discussions.

Skills

Technical Leadership
Systems Engineering
Medical device design
Requirements tracing
Risk management
Cross-functional collaboration
ISO 13485 / 14971

Education

Bachelors in Engineering

Job description

Gore Medical in the United States is seeking a Senior Principal Engineer - Technical Program Leader to own the technical direction and delivery of a new product development program for a complex medical device.

The role combines hands-on engineering leadership with end-to-end accountability from concept through commercialization, partnering with engineering, manufacturing, clinical, quality and regulatory teams.

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