What You Will Do:
We are currently seeking a Principal Design Validation Engineer to join our team in Weston, FL. This is a senior technical leader responsible for defining and scaling design validation strategy for complex medical devices and systems. In this role you will develop new design validation strategies for advanced navigation and surgical robotics programs, shape validation methodology across product portfolios, and drive cross-functional alignment on user needs, requirements traceability, design controls, and evidence generation needed to support safe, effective, and compliant product development and successful regulatory submissions. Your work will directly contribute to bringing new products to market that meet clinical needs and uphold the highest standards of quality and performance.
As a Principal Design Validation Engineer, you will apply core engineering principles across multiple disciplines to drive design validation activities. You will play a critical role in translating high level VOCs to User Needs, developing clinically relevant validation strategies, executing validation studies in different simulated use environments, ensuring that our products meet technical specifications and latest regulatory requirements. This role offers the opportunity to work on a global team in a dynamic, collaborative environment that values innovation, precision, and a commitment to improving patient outcomes.
Technical Responsibilities:
- Lead enterprise-level or multi-program design validation strategy, including validation planning, execution frameworks, statistical rationale, acceptance criteria, and final design validation conclusions for complex hardware, software, and systems-based medical devices.
- Drive development of robust user needs, intended use validation approaches, and end-to-end validation frameworks in partnership with Systems Engineering, R&D, Clinical, Regulatory, Quality, Marketing, and Human Factors teams.
- Define and oversee advanced design validation methods that are objective, clinically relevant, risk-based, and statistically justified for intended users, use environments and surgical workflows.
- Provide technical leadership for complex validation efforts involving cutting-edge navigation and robotics-assisted orthopedic systems and apply in-depth knowledge of the operating room environment to inform test method development, data interpretation and evaluate product performance.
- Provide leadership in setting direction for meeting US AND EU’s latest regulatory requirements for quantitative clinical accuracy design validation methods.
- Lead the integration of diverse medical subsystems into cohesive, customer-ready solutions, optimizing interoperability, workflow efficiency, and overall system performance.
- Mentor and influence in creation and correction of complex design validation test methodologies for product design issues.
- Possesses an in-depth knowledge of the industry and competitive landscape. Partner in generating innovative insights and developing frameworks to prevent field issues by discovering business needs and validating them before product launch.
What You Will Need:
Required Qualifications:
- Bachelor of Science in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Human Factor Engineering or related Lifesciences discipline.
- Minimum 8+ years of work experience validating complex hardware/ software or systems or performing Human Factors/Usability evaluations
Preferred Qualifications:
- Experience in Customer-centric Design, User Needs Research, Accuracy Testing and working through different stages of med tech development.
- Strong understanding of Systems Engineering principles, relevant medical device regulations and standards such as FDA Guidance documents, IEC 62366, 60601-1-6, ANSI HE75.
- Demonstrates mastery in technical writing for complex engineering documentation, including reports, protocols, procedures, and design specifications. Capable of establishing documentation standards, mentoring others in technical writing, and ensuring clarity and regulatory compliance across all deliverables.
- Apply deep understanding of statistical methodologies to guide design validation and integration. Partner with cross-functional teams to interpret data and ensure adherence to design controls and regulatory expectations throughout new product development.
- Exhibit proactive leadership, champion continuous improvement, foster innovation and mentor others in analytical and systematic thinking to achieve high-quality, compliant engineering outcomes.
