
Senior Medical Systems Development Leader
2 weeks ago
- 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.
Schedule includes:
- Support material testing, product specifications, and system integration activities.
- Collaborate with quality assurance, regulatory affairs, manufacturing, and marketing teams to ensure successful delivery and post-market support.
- Conduct risk management activities such as hazard analysis and design failure mode effects analysis.
- Provide technical leadership, mentoring, and direction to cross-functional teams.
- Drive delivery against project timelines while ensuring compliance with industry standards and regulations.
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.
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