Job Summary:
We are seeking an experienced and detail-oriented Principal Engineer to lead the design and development of innovative medical devices. This role requires a deep understanding of design control processes and extensive experience with IEC 62304 for software development in medical devices. You will provide technical leadership, ensure regulatory and quality compliance, and collaborate with cross-functional teams to deliver products that meet the highest standards of safety, quality, and performance.
Key Responsibilities:
- Leadership & Collaboration: Oversee design and development projects, ensuring compliance with design controls and regulatory standards (FDA 21 CFR 820.30, ISO 13485, IEC 62304). Collaborate with cross-functional teams to align design activities with quality, customer, and regulatory objectives.
- Design Control & Compliance: Drive robust design control processes and integrate IEC 62304-compliant software development throughout the product lifecycle. Review and approve design deliverables to ensure accuracy and alignment with regulations.
- Process Improvement & Risk Management: Lead quality process enhancements and stay updated on regulatory changes. Manage risk analyses, root cause investigations, and corrective actions to ensure product safety and compliance with ISO 14971.
- Mentorship & Communication: Mentor engineering teams on design control and software development best practices. Present findings and recommendations to senior leadership, acting as a subject matter expert in compliance and technical strategy.
Qualifications:
- Bachelor's or Master's degree in Engineering
- 10+ years of experience in medical device engineering, with a strong focus on design controls and software development under IEC 62304.
- In-depth knowledge of FDA regulations (e.g., 21 CFR 820.30) and international standards (ISO 13485, ISO 14971, IEC 62304).
- Demonstrated expertise in managing complex projects and ensuring compliance with design controls and regulatory requirements.
- Strong leadership, project management, and problem-solving skills.
