About Us:
iota Biosciences, a wholly owned subsidiary of Astellas Pharma US, is advancing a new class of bioelectronic medicines through the development of fully implantable Class III medical devices. Our proprietary technologies open therapeutic and diagnostic possibilities not previously accessible to clinicians.
Together with Astellas, we are committed to patient-centric design, scientific and engineering excellence, and cross-functional teamwork. These principles guide us in bringing transformative, first-of-its-kind technologies into the clinic and closer to patients.
Role Overview
The Head of Engineering will report directly to the General Manager of the urological therapies program and serve as their key technical advisor. We are looking for a seasoned engineering leader to oversee and advance iota’s engineering and manufacturing functions from pivotal trials through pre-scale and into early commercialization. This leader will oversee all engineering and manufacturing functions, combining strategy, systems engineering expertise, and hands-on leadership. Besides shaping the next-generation platform and long-term product strategy, you’ll influence how we optimize our technology, ensuring it not only meets regulatory milestones but also maximizes impact for patients.
What You’ll Do in This Role
Own the engineering strategy and broader R&D roadmap, guiding both the current clinical device and the next-generation platform to ensure alignment with pivotal trial, PMA, and commercialization milestones
Lead and inspire a multidisciplinary team across electrical, software, firmware, mechanical engineering, and manufacturing engineering to deliver devices that are safe, reliable, and manufacturable at scale.
Oversee the transition from clinical builds to pre-scaling and design transfer, owning supplier qualification, process validation, and readiness for commercial manufacturing.
Balance startup speed with Class III rigor, ensuring engineering decisions meet the highest regulatory standards without slowing innovation.
Roll up your sleeves to solve system-level challenges, bringing deep technical expertise in how electrical, firmware, and mechanical components fit together, and guiding the team through complex systems integration decisions.
Key Responsibilities
Review, refine, and guide the engineering strategy to align with pivotal trial execution, PMA submission, and commercialization milestones, ensuring the team meets both short-term and long-term goals.
Own system architecture and integration across electrical, firmware, software and mechanical components, making informed trade-offs that balance safety, reliability, cost, manufacturability, and clinical usability.
Establish and enforce robust design, design controls, reliability testing, and safety processes that meet or exceed FDA and international standards, including ISO 13485, IEC 60601, IEC 62304, ISO 10993, and ISO 14971, positioning the company for successful regulatory submissions.
Lead, mentor, and scale the engineering team, building technical depth while implementing processes that enable efficient execution, knowledge transfer, and readiness for organizational growth.
Partner closely with Clinical, Regulatory, Product Management, Quality, and Operations to deliver clinical builds, author and defend technical content for submissions, and strategic design transfer and pre-scaling for commercial manufacturing.
Develop and own engineering budgets, resource planning, and timelines, ensuring visibility for leadership while proactively identifying risks and implementing mitigation strategies.
Must-Have Qualifications:
BS in Electrical Engineering, Systems Engineering, or related field.
12–15+ years of medical device experience.
Experience with Class III implantable devices through PMA approval and launch.
Deep systems engineering experience: architecture, integration, verification/validation.
Strong leadership skills with interest in mentoring early-career engineers.
Experience working in a pre-scale or growth-stage company.
Nice-to-Have Qualifications:
Experience with product lifecycle in medical device systems.
Global regulatory experience (CE/MDR).
Manufacturing scale-up and cost-of-goods optimization.
Strategic thinker with hands-on execution ability.
High integrity, adaptability, and ability to thrive in a startup environment.
Why Join Us
This is a rare opportunity to lead engineering at a pivotal stage — shaping technology strategy, mentoring a high-performing team, and directly influencing the launch of a life-changing implantable therapy. You’ll have the autonomy to define the engineering roadmap for next-generation devices and the chance to build products that will change the lives of patients living with underactive bladder.
iota offers a very competitive benefits package that includes the following:
Health & Wellness
Comprehensive health coverage for you and your family, covered at 100%
Access to quality dental and vision coverage
Onsite Gym in Alameda
Work-Life Balance
Generous vacation pay
Paid parental leave
Options for flexible work schedules
Competitive Compensation
Annual Bonus Plan
Long Term Incentive Plan (LTIP)
401(k) plan with employer match
Top Skills
What We Do
iota Biosciences, a wholly-owned subsidiary of Astellas Pharma US, is a medical device company working to develop pioneering bioelectronics to advance the treatment and management of disease. Founded in 2017 to build on the award-winning ultrasound technology invented at the University of California, Berkeley, iota Biosciences is committed to improving human life and bringing our groundbreaking approaches to the patients who need them.
Using innovative science and technology, our mission is to create and develop state-of-the-art diagnostic and therapeutic bioelectronic devices that are safe and effective. We are working to transform the way doctors manage and treat disease to make a life-changing difference for patients.
We are proud and privileged to be powered by Astellas, a leading global pharmaceutical company that brings experience, reach and rigor. With a shared transformational vision and a commitment to the realization of greater value to patients, together we are creating innovative technologies that will change patients’ lives.
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