R&D Tech Lead / Staff Systems Engineer
Company Overview
Our client is a global leader in medical technology, dedicated to developing innovative solutions that improve patient outcomes and advance healthcare worldwide. Their multidisciplinary R&D teams work on cutting-edge devices that combine electronics, mechanics, and software, with a strong focus on safety, reliability, and regulatory compliance. By fostering collaboration and technical excellence, they deliver technologies that make a lasting difference in people's lives.
Role Overview
We are seeking a highly experienced R&D Tech Lead / Staff Systems Engineer to play a pivotal role in guiding the development of advanced medical products. This is a senior-level systems engineering position, where you'll lead a small cross-functional R&D team through the full product lifecycle - from concept and requirements management to commercialization and post-market support.
The role is not hands-on coding but requires strong technical and systems engineering expertise, regulatory alignment, and proven leadership in delivering complex projects. Acting as a central point of contact, you'll ensure timely delivery, robust documentation, and compliance with international standards while mentoring team members and driving innovation.
Key Responsibilities
- Lead systems engineering activities for new and existing R&D projects.
- Oversee the full product lifecycle, including requirements management, risk analysis, and regulatory alignment.
- Manage configuration and change control processes to maintain product integrity.
- Ensure system and sub-system requirements are clear, traceable, and aligned with stakeholder needs.
- Support material testing, product specifications, and system integration activities.
- Collaborate with Quality, Regulatory, Manufacturing, and Marketing to ensure successful delivery and post-market support.
- Conduct risk management activities such as hazard analysis and dFMEA.
- Provide technical leadership, mentoring, and direction to cross-functional teams.
- Drive delivery against project timelines while ensuring compliance with standards such as ISO 13485, ISO 14971, and FDA QSR.
Requirements
- Bachelor's or Master's degree in Engineering, Systems Engineering, Electronics, or related field.
- 5+ years of experience in product development, preferably within regulated industries.
- Strong background in systems engineering, requirements management, and regulatory compliance.
- Proven track record in leading R&D or systems engineering projects through the full lifecycle.
- Knowledge of configuration management and change control processes.
- Excellent communication and leadership skills, with the ability to collaborate across multidisciplinary teams.
This is an exciting opportunity to take on a senior technical leadership role where you'll shape the development of life-changing healthcare technologies. If you're looking to apply your systems engineering expertise in a role with significant impact, we'd love to hear from you.
