Senior Principal Engineer - Technical Program Lead

About the Role

Gore Medical is seeking a Senior Principal Engineer – Technical Program Lead 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, or Flagstaff Arizona with the possibility of a hybrid remote work arrangement, depending upon the responsibilities of the role and business needs.

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 Mechanical or Biomedical Engineering, or equivalent
• 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
• Demonstrated experience applying standard project management tools (e.g., planning, budgeting, scheduling)
• 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 up to 10% of the time

Desired Qualifications

• Project Management skills, including capability in MS Project and critical path management
• Experience working with external development partners or suppliers