Publicerad: 2024-11-22
Embedded Electronics Engineer to Disruptive Novotech
Disruptive Novotech is at the forefront of innovation in wearable neuromodulation medical devices. As a dynamic and fast-growing start-up, the company is passionate about improving healthcare with cutting-edge technology. Join the team and be part of redefining the future of electro-stimulation.
About the PositionWe are looking for an Embedded Electronics Developer to design and implement hardware for a medical electrical stimulator device. This role focuses on PCB design, regulatory compliance, and verification, with expertise in nRF52 microcontrollers, BLE, and analog/digital circuitry. Proficiency in Altium Designer and experience in medical device hardware development are essential.
Key Responsibilities:
- PCB Design & Layout: Create and optimize PCBs in Altium Designer, ensuring BLE functionality, signal integrity, and regulatory compliance.
- Schematic Capture & Component Selection: Develop schematics and select components (e.g., ADCs, DACs, BLE antennas) suited to medical device standards.
- Manufacturing Oversight: Manage PCB manufacturing, vendor coordination, and quality assurance.
- Hardware Documentation: Document hardware development (schematics, layouts, BOM) per ISO 13485 and regulatory standards.
- Compliance: Ensure adherence to IEC 60601, ISO 13485, and EMC standards.
- Verification & Validation (V&V): Develop and execute V&V protocols for hardware functionality, reliability, and safety.
- Collaboration: Work with firmware, QA, and regulatory teams to resolve issues and align processes.
- Prototyping: Prepare prototypes for internal/external testing and feedback.
Ideal candidates bring strong regulatory experience, hardware verification expertise, and a background in medical device development.
This role is ideal for a self-motivated professional who thrives in a fast-paced start-up environment, taking ownership from design to testing while continuously innovating and problem-solving.
- Over 5 years of professional experience in embedded electronics development and PCB layout, preferably within the medical device industry.
- Proven experience with nRF52 series and BLE-enabled hardware design is a strong plus.
- Expertise in Altium Designer for schematic capture, PCB layout, and design rule management, with a strong focus on trace routing, impedance control, and layout optimization for RF and mixed-signal designs.
- In-depth knowledge of analog and digital circuit design with experience in handling signal processing, power regulation, and BLE communication.
- Familiarity with medical device standards (such as IEC 60601 for safety and ISO 13485 for quality management) and regulatory requirements for medical hardware.
- Proficient with testing and debugging tools (e.g., oscilloscopes, multimeters, spectrum analyzers) to verify analog and digital performance and troubleshoot issues.
- Experience producing detailed and regulatory-compliant documentation for firmware lifecycle in line with standards such as IEC 62304.
- Strong documentation skills, with experience creating regulatory-compliant hardware documents per medical standards (ISO 13485, IEC 60601).
- Experience leading verification and validation (V&V) of hardware in compliance-driven environments.
- Holds a Bachelor’s or Master’s degree in Electronics Engineering, Biomedical Engineering or a related field.
- Start: According to agreement
- Place: Central Stockholm
- Salary: According to agreement
We apply an ongoing selection process, which means the position may be filled before the application deadline. Therefore, we encourage you to apply as soon as possible!
If you have any questions or concerns about Asta Agency's recruitment process, don’t hesitate to reach out at ellen@astaagency.se.