Senior Principal Engineer - Technical Program Leader

wlgore; Phoenix (AZ); Hybrid; USD 150,000 - 190,000; Full time

Job summary

Gore Medical Products in Phoenix, AZ is seeking a Senior Principal Engineer – Technical Program Leader to drive the technical direction and delivery of a new medical device development program.

You will serve as the technical decision-maker and system integrator across multidisciplinary teams, guiding architecture, risk management, and end-to-end execution from concept to commercialization in a hybrid work setting.

Qualifications

• Bachelor’s degree in Engineering (Mechanical, Biomedical, or related)
• Minimum of 8 years experience in medical device commercial support and/or new product development
• Demonstrated experience leading within cross-functional new product development programs
• Demonstrated experience in design control, medical device design and development processes that conform to standards including: ISO 13485 and ISO 14971
• Demonstrated experience with technical risk management and problem‑solving methodologies
• Strong written and verbal communication, organizational skills, data analytical skills, and attention to detail
• Experience working with external development partners or suppliers
• Strong business acumen and demonstrated track record of clear decision making and a demonstrated ability to effectively communicate to all levels of leadership within a business / organization
• Experience in creating and maintaining an inclusive work environment with clear understanding of equitable practices
• Ability to travel overnight up to 10% of the time

Responsibilities

• Technical Strategy & Vision: Define and deliver on program technical strategies aligned with business goals and business strategies.
• Technical Leadership & Decision Ownership: Accountable for overall technical outcomes across the program. Make and drive architecture decisions, design trade-offs, integration strategy, and technical direction in alignment with stakeholder requirements, while balancing competing priorities across performance, manufacturability, clinical outcomes, regulatory requirements, and cost.
• New Product Development (NPD) Execution: Lead technical execution across the full product lifecycle (concept → development → verification & validation → launch). Translate business and clinical requirements into engineering solutions.
• System Integration & Cross-Functional Leadership: Lead system‑level integration across all technical domains. Ensure alignment of subsystems, interfaces, and system performance requirements.
• Technical Risk & Problem Solving: Identify and manage technical risks, uncertainties, and failure modes. Lead structured problem solving, trade studies, and risk mitigation strategies (e.g., FMEA, hazard analysis). Navigate ambiguity and drive technical team toward robust, scalable solutions.
• Cross-Functional Influence: Collaborate with and influence across manufacturing, quality, regulatory, clinical, supply chain, and operations teams. Communicate technical strategy, decision rationale, risks, and tradeoffs clearly to stakeholders.
• External Engagement: Lead technical engagement with suppliers, development partners, and external collaborators. Align external requirements to program strategy and technical needs.
• Innovation and IP Strategy: Partner with the legal team on technical landscaping, feasibility studies, ideation, novelty assessments, and creation of IP (e.g., invention disclosures, patents).
• Equity and Inclusion: Establish clear expectations of equitable and inclusive behaviors from Associates and act immediately to appropriately address negatively impactful or unfair behavior.

Skills

Technical Leadership

Systems Engineering

Medical Device Development

Risk Management

Cross-functional Collaboration

Regulatory Knowledge

Vendor Engagement

Travel Ability

Education

Bachelor’s degree in Engineering

Tools

MS Project

Job description

Req Id: 2197

State/Province: Arizona

City:

Business: Gore Medical Products

Category: Engineering, Scientists & Technicians

Sub-Category: Engineering

Experience Level: Senior

Work Arrangement: Hybrid

Posting Start Date: 9/15/26

Posting End Date: 9/30/26

Senior Principal Engineer - Technical Program Leader

Job Description

Gore Medical is seeking a Senior Principal Engineer – Technical Program Leader to lead the technical direction and delivery of a new product development (NPD) program for a complex medical device.

This role combines hands‑on engineering leadership with end‑to‑end technical accountability for decision making, performance, risk identification / mitigation, and successful delivery from concept through commercialization. This role serves as the technical decision‑maker and system‑level integrator across multidisciplinary teams, and works across engineering, manufacturing, clinical, quality, and regulatory, translating business and clinical needs into robust technical solutions.

This position will be located at a facility in Phoenix, Arizona with the possibility of a hybrid remote work arrangement.

Responsibilities

• Technical Strategy & Vision: Define and deliver on program technical strategies aligned with business goals and business strategies.


• Technical Leadership & Decision Ownership: Accountable for overall technical outcomes across the program. Make and drive architecture decisions, design trade-offs, integration strategy, and technical direction in alignment with stakeholder requirements, while balancing competing priorities across performance, manufacturability, clinical outcomes, regulatory requirements, and cost.


• New Product Development (NPD) Execution: Lead technical execution across the full product lifecycle (concept → development → verification & validation → launch). Translate business and clinical requirements into engineering solutions.


• System Integration & Cross-Functional Leadership: Lead system‑level integration across all technical domains. Ensure alignment of subsystems, interfaces, and system performance requirements.


• Technical Risk & Problem Solving: Identify and manage technical risks, uncertainties, and failure modes. Lead structured problem solving, trade studies, and risk mitigation strategies (e.g., FMEA, hazard analysis). Navigate ambiguity and drive technical team toward robust, scalable solutions.


• Cross-Functional Influence: Collaborate with and influence across manufacturing, quality, regulatory, clinical, supply chain, and operations teams. Communicate technical strategy, decision rationale, risks, and tradeoffs clearly to stakeholders.


• External Engagement: Lead technical engagement with suppliers, development partners, and external collaborators. Align external requirements to program strategy and technical needs.


• Innovation and IP Strategy: Partner with the legal team on technical landscaping, feasibility studies, ideation, novelty assessments, and creation of IP (e.g., invention disclosures, patents).


• Equity and Inclusion: Establish clear expectations of equitable and inclusive behaviors from Associates and act immediately to appropriately address negatively impactful or unfair behavior.

Required Qualifications

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


• Minimum of 8 years experience in medical device commercial support and/or new product development


• Demonstrated experience leading within cross-functional new product development programs


• Demonstrated experience in design control, medical device design and development processes that conform to standards including: ISO 13485 and ISO 14971


• Demonstrated experience with technical risk management and problem‑solving methodologies


• Strong written and verbal communication, organizational skills, data analytical skills, and attention to detail


• Experience working with external development partners or suppliers


• Strong business acumen and demonstrated track record of clear decision making and a demonstrated ability to effectively communicate to all levels of leadership within a business / organization


• Experience in creating and maintaining an inclusive work environment with clear understanding of equitable practices


• Ability to travel overnight up to 10% of the time

Desired Qualifications

• Project Management skills, including capability in MS Project and critical path management


• Background in Systems Engineering

This position offers a hybrid work arrangement in the country from which the Associate is employed. Eligibility is dependent on the responsibilities of the role and business needs, and the Associate must agree to comply with Gore’s work arrangement policies.

What We Offer

Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow.

We provide benefits that offer choice and flexibility and promote overall well‑being. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for “profit-sharing”. Learn more at gore.com/careers/benefits

Gore is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a protected veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations.

Gore is committed to a drug‑free workplace. All employment is contingent upon successful completion of drug and background screening. Gore will consider qualified applicants with criminal histories, e.g., arrest and conviction records, in a manner consistent with the requirements of applicable laws.

Gore requires all applicants to be eligible to work within the United States. Gore generally will not sponsor visas unless otherwise noted on the position description.

About Gore

For over 65 years, Gore has improved lives through discovery, product innovation and rewarding careers for Associates. We push the boundaries of what's possible — not just through our products and technologies but also through individual growth and development.

We believe in the strength of a diverse and inclusive workplace. With diverse perspectives, ideas and experiences, we uncover new possibilities and make a greater impact in the world. Our Associates build on a rich history of innovation, upholding Gore’s values and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity and respect.