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Innovative Technical Leader for Medical Products
2 weeks ago
Job Overview:
We are seeking a skilled and experienced technical leader to join our team developing innovative medical products.
- Lead the design and development of new and existing medical products, ensuring alignment with stakeholder needs.
- Define product architectures and translate stakeholder inputs into clear, traceable system requirements.
- Oversee system integration and testing activities, supporting verification and validation across hardware, software, UX, and systems.
- Provide guidance and mentorship to cross-functional teams, promoting engineering excellence.
- Own and maintain design control documentation, SOPs, and requirements using tools like DOORS and Modern Requirements.
- Ensure compliance with ISO 13485, ISO 14971, and support regulatory submissions through collaboration with quality and regulatory teams.
- Conduct risk assessments and implement mitigation strategies, contributing to activities like dFMEA and hazard analysis.
- Work closely with Engineering, Quality, Regulatory, Manufacturing, and Marketing to ensure smooth project execution and post-market support.
About the Role:
- Proven experience in leading technical project teams (HW, SW, UX, Systems) through the product lifecycle.
- Strong ability to lead large teams and communicate technical deliverables effectively.
- Experience in writing SOPs, guidance, and technical documentation.
- Proficiency in Microsoft Project, Excel, especially in writing macros.
- Experience in cross-functional product development.
Requirements:
- Master's degree in Computer Science, Electrical Engineering, or related field.
- Minimum 8 years of experience in technical leadership roles.
- Proven track record of delivering complex projects on time and within budget.
- Excellent communication and interpersonal skills.
- Ability to work in a fast-paced environment and adapt to changing priorities.