Senior Technical Project Manager (m,w,d)

albedis; Zürich; Vor Ort; CHF 110.000 - 160.000; Vollzeit

Zusammenfassung

albedis is seeking an experienced Technical Project Manager for a MedTech client in the German-speaking part of Switzerland. You will lead technical development, verification, validation, and industrialization of medical devices, coordinating cross-functional teams through regulatory gates to market introduction.

Fluency in German and English is required. Strong expertise in design controls, risk management, and regulatory submissions is essential for successful project delivery.

Qualifikationen

• Degree in Mechanical Engineering, Biomedical Engineering or Medical Technology.
• Experience managing technical projects in the medical device industry.
• Knowledge of design controls, V&V, and manufacturing constraints.

Aufgaben

• Lead technical project scope, timelines, budgets, and resources from concept to production readiness.
• Coordinate cross-functional teams across R&D, QA, Regulatory, Clinical, and Manufacturing.
• Ensure compliance with ISO 13485 and MDR during all project phases.
• Drive risk assessments (DFMEA) and lifecycle management for device safety.
• Review and maintain Design History File and documentation for regulatory submissions.

Kenntnisse

Cross-functional leadership

Regulatory knowledge

Project management

DFMEA

3D CAD

Ausbildung

Mechanical Engineering

Biomedical Engineering

Medical Technology

Tools

3D CAD

Jobbeschreibung

For one of my MedTech clients in the German-speaking part of Switzerland, I am currently looking for an experienced Technical Project Manager to join their team. Fluency in both German and English is required for this position.

The Technical Project Manager is responsible for driving the technical development, verification, validation, and industrialisation of innovative medical devices. In this role, you will lead cross-functional teams from the initial concept phase through rigorous medical device regulatory gates to successful market introduction.

Key Responsibilities

• End-to-End Project Execution: Lead the technical project scope, timelines, development milestones, budgets, and resource allocation from initial design through production readiness.
• Cross-Functional Leadership: Coordinate and lead multidisciplinary teams across R&D, Clinical Affairs, Quality Assurance (QA), Regulatory Affairs, and Manufacturing.
• Design Controls & Compliance: Ensure all project phases are executed in accordance with Design Control requirements, ISO 13485, and the European Medical Device Regulation (MDR).
• Risk & Lifecycle Management: Lead risk assessments, tolerance analyses, and Design Failure Mode and Effects Analysis (DFMEA) to ensure product safety, reliability, and mechanical performance throughout the product lifecycle.
• Technical Documentation: Review, maintain, and ensure the completeness of the Design History File (DHF) and all relevant engineering documentation required for global regulatory submissions.

Your Profile

• Education: Degree in Mechanical Engineering, Biomedical Engineering, Medical Technology, or a comparable technical discipline.
• Experience: Proven experience managing technical projects and/or product development within the medical device industry; experience in implantology is highly desirable.
• Technical Expertise: Strong knowledge of precision mechanical design, tolerance stack-ups, and experience with 3D CAD tools.
• Process Knowledge: Practical understanding of quality management systems, verification and validation (V&V) processes, and manufacturing requirements and constraints.
• Project Leadership: Demonstrated ability to lead cross-functional teams, manage multiple stakeholders, and drive projects effectively within a regulated environment.