Join our company as a senior R&D tech lead / staff systems engineer. This role is dedicated to developing innovative solutions that improve patient outcomes and advance healthcare worldwide.
We are seeking a highly experienced professional to guide the development of advanced medical products through the full product lifecycle - from concept and requirements management to commercialization and post-market support.
* 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.
Key Responsibilities
Schedule includes:
1. Support material testing, product specifications, and system integration activities.
2. Collaborate with quality assurance, regulatory affairs, manufacturing, and marketing teams to ensure successful delivery and post-market support.
3. Conduct risk management activities such as hazard analysis and design failure mode effects analysis.
4. Provide technical leadership, mentoring, and direction to cross-functional teams.
5. Drive delivery against project timelines while ensuring compliance with industry standards and regulations.
Requirements
The ideal candidate will have:
* 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.