Electronics Engineer Medical Devices (medior/senior)

Role summary

The Electronics Engineer is responsible for the design, development, and lifecycle support of the electronics in Novuqare's product portfolio, including the MAPLe pelvic health system, the ProSeal rotary pouch sealer, and OEM products. The role covers schematic design, PCB/PCBA design, prototyping, verification, and design transfer to production, and ensures that electrical designs meet applicable safety and EMC standards (IEC 60601 series) within the company's ISO 13485 and ISO 9001 quality framework. Working in a small, multidisciplinary team, the role combines hands-on engineering with ownership of technical documentation and compliance evidence.

Key responsibilities

• Design and develop analog and digital electronics for new products and product improvements, from architecture and schematic capture through PCB layout and PCBA realization.
• Ensure electrical designs comply with IEC 60601-1 (basic safety and essential performance) and IEC 60601-1-2 (EMC), including creepage/clearance, means of protection, applied part isolation, and dielectric requirements for medical devices.
• Design and verify analog front-end circuitry for biosignal acquisition (EMG) and electrical stimulation output stages, ensuring compliance with the applicable particular standards (IEC 60601-2-10, IEC 60601-2-40).
• Prepare and maintain design documentation for the technical file and design history: schematics, layout data, BOMs, design calculations, and verification reports, in line with MDR 2017/745 design control and document control requirements.
• Plan and execute design verification: prototype bring-up, bench testing, EMC pre-compliance testing, and coordination of third-party test-house campaigns (60601 safety and EMC).
• Contribute to risk management activities (ISO 14971) by identifying electrical hazards, defining risk control measures in the design, and providing verification evidence.
• Select components with attention to reliability, medical-grade requirements, obsolescence, and supply chain continuity; manage component changes through the change control process.
• Support design for manufacturability and testability (DFM/DFT), including test fixture definition, in-circuit and functional test specifications, and support of contract manufacturers and PCBA suppliers.
• Provide sustaining engineering for released products: root-cause analysis of field returns and complaints, support of CAPA investigations, and implementation of design changes.
• Collaborate with embedded software development: define hardware/software interfaces, support firmware bring-up and debugging, and where possible contribute to embedded software development and testing.
• Support production with work instructions, test procedures, and troubleshooting of electronics-related production issues.
• Monitor developments in relevant standards (IEC 60601 series, EMC, IEC 62304) and assess their impact on current and future designs.

Profile

• Bachelor's or Master's degree in Electrical Engineering, Electronics, or a related field.
• Approximately 3–8 years of experience in electronics design, preferably in medical devices or another regulated industry.
• Demonstrable experience designing to IEC 60601-1 and IEC 60601-1-2, or a strong track record with comparable product safety and EMC standards and the willingness to become the in-house 60601 expert.
• Strong PCB/PCBA design skills: schematic capture, multilayer PCB layout, signal integrity and EMC-aware design, using tools such as Altium Designer, KiCad, or equivalent.
• Experience with mixed-signal design and low-noise analog front-ends (amplification, filtering, ADC interfacing) for small-signal measurement.
• Hands-on prototyping and debugging skills: soldering, lab instrumentation (oscilloscope, DMM, EMC pre-scan tools), and structured fault-finding.
• Experience with embedded software (C/C++ on microcontrollers) is preferred; familiarity with IEC 62304 is an advantage.
• Experience with biopotential measurement (EMG, ECG, EEG) and/or electrical stimulation circuits is a strong advantage; familiarity with digital signal processing is a plus.
• Experience working within an ISO 13485 or ISO 9001 QMS, including design control, change control, and document-controlled processes, is preferred.
• Pragmatic, self-organizing, and comfortable owning topics end-to-end in a small company where roles are broad.
• Fluent in English; Dutch is an advantage.

Core competencies

• Strong analytical and problem-solving skills.
• Quality- and compliance-minded without losing pragmatism.
• Hands-on mentality and ownership of results.
• Clear technical communication, verbal and written, toward engineers, suppliers, and auditors.
• Team player in a small, multidisciplinary medtech environment.
• Eagerness to keep learning across disciplines (hardware, firmware, compliance, production).

What success looks like

• Electrical designs pass 60601 safety and EMC testing with minimal iterations.
• Technical documentation is complete, current, and audit-ready for notified body and certification audits.
• New product electronics progress from concept to verified design on plan.
• Released products are supported proactively: field issues are analyzed and resolved through structured root-cause analysis and change control.
• Production and suppliers receive clear, workable documentation and support.
• The company's in-house electronics and 60601 competence is strengthened and less dependent on external parties.

Recruitment based on this vacancy is not appreciated.

Salaris: €4.500,00 - €6.000,00 per maand

Arbeidsvoorwaarden:

• Pensioen
• Reiskostenvergoeding

Werklocatie: Fysiek