Senior Principal Engineer - Technical Program Leader

W. L. Gore & Associates, Inc.; Phoenix (AZ); Hybrid; USD 150,000 - 210,000; Full time

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

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

• Choice and flexibility and promotion of overall well-being.
• Associate Stock Ownership Plan in each country as well as potential opportunities for "profit-sharing".

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.