Head of Hardware
Chipiron
- Paris
- CDI
- Temps-plein
- Proven track record leading complex hardware product development; in the medical industry is a plus; in the MRI industry is a strong plus.
- Engineering degree (Mechanical, Electrical, Biomedical, or related field); advanced degree is a plus.
- 5+ years of leadership experience managing multi-disciplinary engineering teams (electronic, mechanical, embedded, imaging or MRI).
- Strong experience in medical device development, with a deep understanding of ISO 13485 and IEC 60601 compliance.
- Hands-on exposure to MRI system design (magnetics, RF coils, gradient amplifiers, shielding) is a strong plus.
- Experience managing full product lifecycle: prototyping, design transfer, industrialization, and sustaining.
- Skilled in cross-functional collaboration, particularly with software, regulatory, and product teams.
- Excellent communication and project management skills with a solution-oriented mindset.
- Lead cross-functional hardware engineering teams (Electronics, Mechanics, MRI Validation) through full development cycles, from concept to production.
- Act as owner of the Hardware Design & Development process, aligning with ISO 13485 and IEC 60601 standards.
- Shape and grow a multidisciplinary team of 15+ engineers, creating a high-performance, accountable, and agile culture.
- Develop and execute strategic plans for hardware development aligned with product milestones.
- Participate in Design Reviews and Management Reviews, ensuring design integrity and regulatory compliance.
- Serve as a key stakeholder in project reviews, reporting on progress, risks, and mitigation strategies to internal leadership.
- Identify, track, and mitigate technical risks, dependencies, and roadblocks across the development lifecycle.
- Ensure smooth coordination between internal teams (Software & AI, MRI Validation, ME, Product, Regulatory).
- Interface with external vendors and manufacturing partners for design transfer, production support, and logistics coordination.
- Drive design for manufacturability, cost reduction, and quality improvement while maintaining speed to market.
- Act as owner or reviewer for CAPA and Change Control processes related to hardware development.
- Contribute to regulatory submissions and the creation of technical documentation, ensuring alignment with global medical device standards.
- Collaborative Decision-Making;
- High Standards and Autonomy: We maintain high expectations for our team members and offer complete autonomy, coupled with incentives tied to the company's success, fostering a culture of ownership and accountability;
- Value of Humility: We prioritize seeking the truth over being right;
- English-First International Team.