Senior Principal Engineer - Technical Program Lead

Responsibilities

• Define and deliver on program technical strategies aligned with business goals and business strategies.
• 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.
• Lead technical execution across the full product lifecycle (concept → development → verification & validation → launch). Translate business and clinical requirements into engineering solutions.
• Lead system-level integration across all technical domains. Ensure alignment of subsystems, interfaces, and system performance requirements.
• 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).

Requirements

• 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

Qualifications

• Required Qualifications
• Desired Qualifications