Head of R&D and Operations (Medical Device)

Singular Medical, Singular Medical is a cardiac rhythm management (CRM) device company founded in 2017 and headquartered in Suzhou, China, with an R&D center in Irvine, California. Singular Medical US is an independent American medical device company — incorporated and operating as a standalone entity, with its own product roadmap, IP ownership, regulatory strategy, and long-term commercial ambitions in the US and global markets. This is not an R&D outpost or a satellite office. It is a company in its own right, backed by a well-capitalized parent with proven CRM development and manufacturing capabilities.We are looking for the leader who will build it. Starting with a focused team of 4 engineers in Irvine, you will grow the organization, drive priority product programs (EV-ICD lead, S-ICD lead, leadless pacemaker), own the US regulatory and clinical pathway, and over time establish Singular Medical as a recognized name in the US cardiac device market. You will have full accountability for the US entity — its people, its programs, its partnerships, and its future — and the organizational support to execute at the highest level.Key ResponsibilitiesThis role has a clear primary focus and a broader ownership mandate. Your core value is structural and mechanical expertise — you will personally lead the development of EV-ICD leads and leadless pacemaker from the ground up. At the same time, you are the Head of the US entity, which means you own all US programs, including ongoing EE, firmware, and software development work. For those programs, your role is program leadership — setting direction, maintaining accountability, and ensuring the team delivers — not deep technical execution. You don't need to be the expert in every domain. You need to be the leader every program can count on.1. Lead New Product Innovation — Your Core ContributionOwn and drive the EV-ICD lead and leadless pacemaker development programs from day one — starting with technical research, structural design concepts, IP landscape assessment, and feasibility definition.Apply your ME expertise directly: lead design decisions on structural mechanics, material selection, fixation mechanisms, miniaturization, and long-term implant reliability.Execute through the right mix of resources — your own hands-on judgment, external consultants with cardiac lead expertise, CDOs, or academic partners. You are responsible for the outcome, not just the process.Proactively identify and file IP as programs develop. Cardiac lead structures, fixation innovations, and novel device architectures are a strategic priority for the US entity.Identify and close at least one substantive US partnership within the first 1–2 years — co-development, licensing, or clinical collaboration that accelerates either program.2. Own All US Programs as Program LeaderTake program management ownership of all active Irvine programs — including dual-chamber ICD development, ASIC and firmware work, DF-4 lead collaboration with Integer, and CSP lead prototyping — even where the technical depth sits with the EE and software engineers or the global R&D team.Establish and maintain clear milestones, program dashboards, risk tracking, and documentation standards across all programs. Every program has an owner — and that owner is you.Serve as the primary point of accountability between the US team and global R&D — ensuring alignment on priorities, timelines, and technical decisions without creating bottlenecks.You are not expected to be the technical expert in EE, firmware, or ASIC development. You are expected to ask the right questions, identify risks early, and make sure the right people are solving the right problems.3. Build & Lead the US TeamIntegrate with the existing team of 4 engineers (EE and software) — build trust, understand their work, and gradually assume full management responsibility through a collaborative transition.Grow the team intentionally as programs and funding require — prioritizing hires that complement your own ME background, including regulatory, quality, and additional engineering talent.Build the external network the team depends on: consultants, contract manufacturers, clinical advisors, and university partners that extend your capabilities beyond headcount.What We're Looking ForWe are not looking for the most experienced person in the room. We are looking for the most driven. The right candidate has strong technical foundations, genuine curiosity about cardiac devices, and the hunger to build something that hasn't been built before. Prior CRM experience is not required — what matters is the engineering depth, the leadership instinct, and the ambition.Core RequirementsSolid mechanical engineering (ME) foundation — hands-on experience designing implantable or interventional devices. You understand materials, structural mechanics, miniaturization, and long-term reliability in the body.Cross-disciplinary program leadership — you've owned programs that involved EE, firmware, or software components you didn't personally execute. You know how to lead engineers outside your own domain: ask the right questions, track the right risks, and hold people accountable without micromanaging.Familiarity with cardiac or cardiovascular anatomy — you don't need to have worked in CRM, but you need to understand how the heart works and why device design decisions matter clinically.Awareness of the FDA regulatory framework for Class II/III devices — you don't need to have led a submission yourself, but you understand the process and know how to build the right team and advisory resources to execute it.8+ years in medical device development, with hands-on involvement from early-stage design through V&V, and demonstrated accountability for program outcomes across functions.Backgrounds We're Actively ConsideringStructural heart or vascular intervention — catheter and delivery system design, cardiac anatomy, transcatheter implant development. Direct transferability to EV-ICD lead and leadless pacemaker programs.Implantable cardiac monitoring or heart failure devices — closed-loop system architecture, implantable pressure/hemodynamic sensors, wireless systems. Experience with connected implantable platforms is highly relevant.Neuromodulation (spinal cord stimulation, deep brain stimulation, peripheral nerve) — lead design, implantable systems, long-term chronic reliability. Highly transferable structural and systems experience.Cardiac rhythm management (ICD, pacemaker, ICM) — direct domain knowledge, though not required.Any implantable device field where you've owned complex system development from early concept through clinical trial — and where the device had to work reliably inside the body for years.How to Apply:Interested candidates are invited to send their resume and a cover letter to ellenlan@kingfisherchina.com