Principal Product Development Engineer
Job Title: Principal Product Development Engineer - Heart Failure Devices
Location: Irvine, CA
Department: Research & Development
Reports to: Director of Product Development
Employment Type: Full-Time
Position Summary:
We are seeking a seasoned Principal Product Development Engineer to lead the design and development of next-generation medical devices for the treatment and management of heart failure. This role is pivotal in transforming clinical needs into innovative, safe, and effective products that improve patient outcomes. You will act as a technical leader, mentor, and key contributor throughout the product lifecycle-from concept through commercialization.
Key Responsibilities:
Lead end-to-end product development activities for heart failure medical devices, including implantable and external systems.
Serve as technical lead and subject matter expert across cross-functional teams (R&D, Quality, Regulatory, Clinical, Manufacturing).
Translate clinical needs and user requirements into detailed design inputs and specifications.
Perform and oversee design feasibility, risk analysis, prototyping, testing, and design verification/validation.
Partner with physicians, clinical advisors, and marketing teams to gather voice-of-customer (VOC) insights and ensure clinical relevance of product designs.
Drive design control processes and ensure compliance with FDA 21 CFR Part 820, ISO 13485, and other relevant regulatory standards.
Lead design reviews and present technical findings to internal stakeholders and external collaborators.
Mentor junior engineers and contribute to team development through knowledge sharing and coaching.
Collaborate with manufacturing to ensure design for manufacturability (DFM) and design for reliability (DFR).
Participate in regulatory submission activities, including generation of technical documentation for IDE, PMA, or 510(k) submissions.
Qualifications:
Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, or related field. PhD is a plus.
Minimum 10 years of experience in medical device product development, with at least 5 years in cardiovascular or heart failure technologies.
Proven track record of leading complex product development projects from concept to commercialization.
Deep understanding of cardiovascular physiology and implantable or monitoring systems for heart failure treatment (e.g., hemodynamic sensors, LVADs, CRTs).
Strong knowledge of materials, biocompatibility, mechanical design, and fluid dynamics in the context of medical devices.
Experience with CAD tools (e.g., SolidWorks), FEM analysis, and rapid prototyping technologies.
Familiarity with design controls, risk management (ISO 14971), and standards such as IEC 60601, ISO 10993, etc.
Excellent leadership, communication, and project management skills.
Preferred Experience:
Experience with class III devices and PMA submissions.
Hands-on experience with preclinical testing, animal studies, or clinical trial support.
Prior collaboration with electrophysiologists, cardiologists, or heart failure specialists.
What We Offer:
Competitive compensation and benefits
Opportunity to work on life-changing innovations
Collaborative and mission-driven work environment
Continuous learning and professional development
Join us in redefining what's possible in heart failure care.
Apply now and be part of a team driving innovation in cardiovascular health.
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