For our customer located in Basel/Switzerland we are currently looking for a: Health Risk and DHF Engineer (m/f/d)
- Location: CH-4056 Basel
- Branch: pharma
- Duration: 10 months +
Tasks & Responsibilities
The Connected Health Ecosystems & Operations team is looking for an experienced medical device engineer to lead the risk management activities for Connected Health products, as well as authoring additional design history file documents as required. Each product includes a variety of components such as a drug delivery device, mobile phone app and cloud based data storage. The ideal candidate contributes to the development and life-cycle management of complex medical devices and software as a medical device (SaMD) projects using state-of-the-art risk management methods and requirements management tools such as Polarion.
This highly interactive role will work with cross-functional teams to develop and implement a risk management methodology that integrates with model based systems engineering. Risk will be managed at the system and sub-system level, which may include injection and diagnostic devices, as well as software modules running on multiple hardware platforms. End-to-end thinking will see hazard and risk assessments being translated into criticality assessments for pharmaco-vigilance and technical complaint categories. A platform approach must also be developed which allows risk management to be applied to multiple projects and drug assets in an efficient manner. With a good understanding of medical device development, this person will also be able to author additional design history file documents as required by the project team.
- Design and implement risk management approach to support the development and life cycle management of complex products and platforms in the areas of connected drug delivery devices and medical device software including SaMD
- Implement risk management at systems level and co-ordinate risk management activities at component level for an integrated risk management file
- Use tools such as Polarion for capturing risk management data and generating the necessary documentation, as well as tracing hazards and risks from system to component level
- Actively maintain and monitor the traceability from the requirements to the verification activities
- Integrate information security risk management requirements into the risk management process such as cybersecurity and data privacy
- Write and maintain risk management plans, hazard analyses and design FMEAs
- Translate risk assessments into effective control strategies, technical complaint categories and escalation categories for adverse events
- Update risk files based upon real-world evidence from clinical and commercial products
- Be the risk management representative for communications with cross-divisional teams, programs, and stakeholders
- Author relevant design history files and GMP compliant documentations
- Excellent problem-solving skills with an analytical mind
- Bachelor or more advanced degrees in Biomedical Engineering, Systems Engineering, Electrical/Electronic Engineering, Computer Science, or other relevant disciplines
- Minimal 5 years of experience in medical device development, or other highly regulated industries
- Strong communication skills for both technical discussions with dev team and also for alignments with business stakeholders
- Prior experience covering the medical device and/or SaMD product development from concept to commercial launch
- Experience working with the requirements and traceability management tools
- Well-versed in medical device or SaMD development, Quality Management System, and regulatory processes (ISO 13485, ISO 14971, IEC 60601, 62304, 82304)
- Systems and system of systems thinking with good abstraction skills
- Expertise in medical device development and life-cycle regulations with a focus on risk management
Nice to Haves
- Ability to decompose to device and software sub-systems. Domain modelling experience and linking to requirements definition and management
- Detailed knowledge of using requirements management tools, previous experience of Polarion
- Expertise in SW development and SW architecture a plus, as well as cyber security and data privacy
Did we catch your interest?
The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).
Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.
Preferred Interview Dates