Senior Principal Engineer - Medical Device NPD Leader

W. L. Gore & Associates; Arizona; Hybrid; USD 140,000 - 210,000; Full time

Job summary

Gore Medical seeks a Senior Principal Engineer – Technical Program Leader to direct a complex medical device NPD program from concept through commercialization. Located in Phoenix, Arizona, with a hybrid work option, the role blends hands-on engineering leadership with end-to-end accountability across cross‑functional teams including manufacturing, quality, regulatory, and clinical.

You will own technical strategy, drive architecture decisions, manage risk, and engage suppliers and external

Qualifications

• Bachelor’s degree in Engineering (Mechanical, Biomedical, or related).
• 8+ years experience in medical device development or support.
• Leading cross-functional NPD programs.
• Experience with design controls per ISO 13485/14971.
• Strong communication, organizational and analytical skills.
• Experience with external development partners or suppliers.
• Willingness to travel up to 10%.

Responsibilities

• Define and deliver program technical strategies aligned with business goals.
• Make architecture decisions and drive technical direction across the program.
• Lead NPD execution through concept to launch and verification/validation.
• Oversee system integration and cross-functional coordination.
• Identify and mitigate technical risks; lead structured problem solving.
• Collaborate with manufacturing, quality, regulatory, and clinical teams.
• Engage with suppliers and external partners to align requirements.
• Support IP strategy and foster inclusive, equitable behaviors.

Skills

Communication skills

Analytical skills

Organizational skills

Attention to detail

Cross-functional collaboration

Education

Bachelor's degree in Engineering (Mechanical, Biomedical, or related)

Tools

MS Project

Systems Engineering

Design controls (ISO 13485/14971)

Job description

Gore Medical seeks a Senior Principal Engineer – Technical Program Leader to direct a complex medical device NPD program from concept through commercialization. Located in Phoenix, Arizona, with a hybrid work option, the role blends hands-on engineering leadership with end-to-end accountability across cross‑functional teams including manufacturing, quality, regulatory, and clinical.

You will own technical strategy, drive architecture decisions, manage risk, and engage suppliers and external