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Tier-1 employer, metro location, and broad cross-functional program scope increase competition.
High because role requires deep medical-device regulatory and program management expertise.
High due to explicit 18+ years, regulated medical-device leadership, and standards knowledge requirements.
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Lead planning and execution of large, cross-functional engineering programs for Neuromodulation and Pelvic Health therapy platforms.
Own integrated program delivery across software, systems, firmware, hardware, ensuring compliance with FDA and global regulatory requirements.
Manage risk, dependencies, milestone reviews, design transfer, and executive communication for software-intensive medical device programs.
Bachelor’s degree in Engineering, Computer Science, or related discipline.
18+ years overall experience including 8+ years in engineering or program management leadership in regulated product development.
Strong knowledge of IEC 62304, ISO 14971, FDA regulations, and Design Controls.
Work Experience Required: 18+ years with 8+ years in leadership within regulated industries, 5+ years hands-on software engineering experience (preferably mobile).
Experienced in leading complex, software-enabled medical device programs under regulatory compliance in a global matrix environment.
Skilled in balancing speed, quality, compliance, and business outcomes with strong influencing capabilities across multiple stakeholders.
Background in mentoring senior program managers and advancing program management best practices in regulated medical or similar industries.