Senior Scientific Technical Leader
An opportunity has arisen for a talented Senior Scientific Technical Leader to support technical strategy and collaboration with external development for upcoming projects. This role in Switzerland with an opportunity to work with an established pharmaceutical company.
- Leads the technical development of safe, user-centric, efficient and robust Connected Health solutions
- Leading authoring, reviews and approval of product Design History File documentations within the applicable documentation system (e.g. Subway, Polarion)
- Provides expertise for Connected Health products within broader cross?functional development teams; in particular with regard to regulatory requirements (eg. MDR, CFR), normative standards (e.g. ISO 13485, IEC 62304, IEC 82304, IEC 62366-1, ISO 14971)
- Supports the standardisation of the entire life cycle management process in order to utilise cross?product synergies
- Manage vendors and ensure work / deliverables in a harmonised way with Novartis design controls process and tools.
- Supports the technical strategy and collaboration with external development partners
- Contributes to supplier evaluation, selection, auditing and approval
- Creates development plans and contracts for upcoming projects
- Executes work packages, monitors work progress according to project plan and reviews deliverables third parties
- Monitors, supports and challenges technical development and deliverables as well as change, verification & validation and release strategies
- Review of deliverables from suppliers ( part of development sprint reviews )
- Proactively identifies potential issues, plans contingency and mitigations
- Manage technical interfaces with NBS IT DHP to host applications into Novartis cloud platform.
- Liaising with the relevant stakeholders for the technical aspects of the assigned project
- Supports RA to assess device classification, prepare specific pre-registration documents and provides input to answer health authority questions.
- Builds (internally or by outsourcing) demonstration prototypes to allow for early characterization testing
- Drives for excellence according to latest best practices in leading root cause, troubleshooting and failure investigations
Skills and Requirements
- Masters/Bachelor degree in Computer science, Electronics, or some other relevant field
- 5-8 years of experience in Software Development/SaMD projects ideally using design controls
- Strong knowledge in applicable medical device regulatory requirements (i.p. ISO 13485, IEC 62304, IEC 82304, IEC 62366-1, ISO 14971
- Experience in agile framework
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.