Principal Product Engineer for Medical Devices - AQMed

About the Role

As a Principal Product Engineer, you will continuously evaluate learnings and new capabilities from customers & internal R&D, respectively, and incorporate them into CardiAQ™ hardware products. You are a deeply experienced biomedical engineer and a highly effective engineering decision-maker. You are collaborative yet pragmatic when making decisions, and you carefully consider the impact of your decisions on customer satisfaction, product performance, usability, manufacturability, time-to-market, and cost. You’ll bring your unique regulated-device development experience to the team to ensure CardiAQ™ delivers maximal impact on patient care decisions with awe-inspiring speed to commercialization. 

You are comfortable making and explaining design choices across distributed engineering teams and at the intersection of multiple engineering disciplines. You have “been there, done that, and know what good looks like” when launching diagnostic medical devices into V&V testing, clinical studies, and commercial usage.

What You’ll Do

• Own the engineering development of product features across electrical, mechanical, systems, and human factors disciplines. Document the development process to meet the necessary compliance requirements (e.g., Design History File, Technical File, Risk Management Process, etc.) 
• Accelerate our contract design/engineering + manufacturing partners by reducing their time to act on product feature decisions & innovations.
• In coordination with Quality, our CMs, and R&D drive the development of the V&V + test systems for sensor-level and system-level acceptance.
• Design and implement a feedback mechanism to receive timely product feedback from not only customers but also manufacturer partners. Possess an action-oriented mindset to address feedback promptly and effectively.   
• In collaboration with R&D, define and iterate hardware product roadmap to ensure compatibility with other critical aspects of our product offering, including Data Science/ Machine Learning & Platform to meet business objectives.

About You

• 10+ years in medtech product engineering, preferably developing Class II or III regulated devices through market clearance studies.
• Experience in product development from concept development (stage 0-3) through commercialization (stage 4+)
• You have deep technical expertise in the key medtech product development disciplines: mechanical, electrical, human factors / usability / industrial design, and systems engineering. 
• You’ve successfully collaborated with outsourced engineering resources and contract manufacturing partners.
• You are experienced in collaborating with Clinical, Regulatory, and Quality when launching medtech products.
• You drive technical decisions with the North Star of solving unmet clinical needs while incorporating the insights and contributions of skilled colleagues on your team.  
• You effectively communicate at the executive level, ensuring decisions are clearly linked to business objectives and routed to engineering teams for efficient action.
• Action-oriented: you proactively create solutions, knowing that a delay in our product launch means a delay in impacting patient care.
• You are willing and able to work from our Palo Alto location 80% of the time (hybrid). 

Nice to Haves

• You’ve worked on multiple complex capital equipment, sensing or robotic devices in the past.
• You’ve supported medtech product market clearance/approval applications in both the US and OUS. 
• Cardiovascular device/cardiology experience and familiarity/expertise in the electrophysiology of the heart.

The US base salary range for this full-time position is expected to be $250k-$350k per year. Our salary ranges are determined by role and level. Within the range, individual pay is determined by factors including job-related skills, experience, and relevant education or training. This role may be eligible for annual discretionary bonuses and equity.