Beschreibung
For my Medical Device client in Switzerland, I am recruiting for a Technical Lead for Embedded software components within their range of medical devices which include auto-injectors and pumps.
Responsibilities
- Lead technical development activities for Embedded software components of medical devices used in combination products, eg auto-injectors, pumps.
- Specify requirements (DIR) of software components and define architecture for future platforms, including liaison with teams developing Novartis Digital Ecosystem.
- Working with human factors engineers to define the appropriate HMI and activities.
- Collaborate with electronics experts to ensure appropriate hardware defined for software requirements.
- Manage suppliers in the detailed software design, coding and documentation with consideration of medical device classification.
- Ensuring fail-safe operation through architectural design as well as Real Time error checking to prevent logical, numerical or HMI errors.
- Applying security protocols for wireless communication to pair and operate components of the system.
- Ensuring data security and integrity with consideration of FDA CFR Part 11.
- Planning and reviewing the verification and validation of the software to ensure safe and secure operation with attention to hardware and operating system environment and versions.
- Generate Design Controls documentation while contributing to a high-quality Design History File (DHF) for parenteral delivery injection systems. Author and Reviewer of DHF documents such as Design Input Requirements, Component Specifications, Design Verification Plan and Verification Summary Report. Ensure quality and compliance to applicable regulations of the DHF elements of the assigned projects.
- Ensure device design development in compliance with the regulations and delivered to a high quality.
- Root cause analysis of out-of-specification product and develop robust solutions to prevent re-occurrence.
Requirements:
- An ideal candidate would have at least 8 years of experience in software development with main focus on medical devices for parenteral administration.
- The ideal candidate would have experience generating DHF documentation, including but not limited to design input requirements, technical specifications, design verification, design validation, and design transfer. They are organized and structured in their approach and able to drive a technical team to reach solutions that meet with drug development milestones.
- Excellent technical writing skills (eg, Design Controls)
- Good understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive)and of combination products (US) and standards
- General understanding of Human Factors Engineering and Risk management
- General understanding of pharmaceutical development
Michael Bailey International is acting as an Employment Business in relation to this vacancy.