Clinical Engineer, Cardiac Devices — Evidence & Trials Lead

HighTechXL; Eindhoven; Hybrid; EUR 60,000 - 85,000; Full time

Benefits offered by this job

Stock Appreciation Rights

Direct collaboration with founders

Access to CARIM / MUMC+ partnership

Job summary

SonicPrecision is seeking a Clinical Engineer/Clinical Scientist to build and execute our clinical evidence strategy. You will work directly with the founders and the R&D team to develop clinical evidence, engage leading electrophysiologists, and translate clinical insights into product and regulatory requirements.

You will design and run studies with CARIM/MUMC+, help prepare CER and CIP for First-in-Human, and support CE marking under EU MDR and FDA approvals for a Class III device.

Qualifications

• Education: Master’s or PhD in biomedical engineering, clinical sciences, medicine, or related life sciences; background in interventional cardiology, electrophysiology, or medical devices is a strong advantage.
• Experience: 1–3 years; we do consider recent graduates with a strong clinical or MedTech graduation project
• Clinical knowledge: Familiarity with cardiac electrophysiology, catheter ablation, or interventional cardiology from clinical research, internship, or graduation project
• Regulatory awareness: Basic understanding of EU MDR, clinical evaluation processes, or GCP/ISO 14155 is beneficial; willingness to build expertise in this area is essential
• Communication: Clear writing and confident presentation to clinicians, regulators, and investors; fluent in English
• Mindset: Structured, curious, and comfortable in a small team where not everything is organised yet; you take ownership and ask for help early when you need it
• Travel: Able and willing to travel occasionally

Responsibilities

• Execute and update the clinical evidence roadmap: study design, publication strategy, and reports from pre-clinical validation through First-in-Human and approval
• Help design and run pre-clinical studies with CARIM / Maastricht University Medical Centre (MUMC+): protocols, data collection, and endpoints
• Contribute to the Clinical Evaluation Report (CER) and Clinical Investigation Plan (CIP) for First-in-Human, working with regulatory advisors on CE marking under the EU MDR and FDA approval for a Class III device
• Build our clinical network: find and engage senior electrophysiologists (KOLs) who can act as trial investigators, advisory board members, and early adopters
• Represent SonicPrecision at scientific conferences (ESC, HRS, Europace, EHRA) and contribute to abstracts and posters
• Turn clinical insights and physician feedback into clear product requirements, together with the engineering team
• Follow the literature and new technologies in catheter ablation (VT, AF, PFA, RF, cryoablation, mapping) and feed what matters into our product strategy and evidence plan

Skills

Clinical knowledge

Regulatory awareness

Communication

English fluency

Ownership mindset

Willingness to travel

Education

Master’s or PhD in biomedical engineering or life sciences

Job description

SonicPrecision is seeking a Clinical Engineer/Clinical Scientist to build and execute our clinical evidence strategy. You will work directly with the founders and the R&D team to develop clinical evidence, engage leading electrophysiologists, and translate clinical insights into product and regulatory requirements.

You will design and run studies with CARIM/MUMC+, help prepare CER and CIP for First-in-Human, and support CE marking under EU MDR and FDA approvals for a Class III device.