Responsibilities
* Project Leadership & Strategy: Act as the technical lead for instrument hardware product care team (devices for Nucleic Acid Purification, PCR and Sequencing, on maintaining and optimizing complex diagnostics systems), driving work package planning, implementation and resource allocation with line management
* Financial & Progress Control: Accountable for budgeting and controlling hardware project development costs for product care, CoGP (Cost of Goods Produced), and overall project progress
* Technical Design & Specifications: Create, approve, and manage concepts, requirements and specifications for the life cycle management of the products in scope
* Quality & Reviews: Lead technical reviews and design/redesign challenges at all levels (including PCBA/Firmware), approve technical changes, and oversee the DQM (Design Quality Management) process and negotiate changes with the product business management team
* Verification & Delivery: Ensure the delivery of tested units and oversee the planning, execution, and documentation of technical verification in coordination with Test Managers and Product Owners
* Risk Management: Manage hardware project (engineering change) risks within the area of responsibility and serve as a member of the Product Risk Assessment team
* System Integration: Support Integration Development and Design V&V, resolving interface issues and technical clarifications with architects and system engineers
* Stakeholder & Vendor Management: Manage relationships with external partners (suppliers/engineering) and align with internal stakeholders (Business, Development Project Leaders, Operations, Line Managers) through frequent reporting
* Cross-Functional Collaboration: Facilitate cooperation across functions (Software, Operations, Supply Chain), acting as the primary contact for module-specific questions
Background
* Degree in a relevant life science discipline (e.g. mechanical or electrical engineering related to life sciences) or corresponding job experience as Technical Project Leader
* Min. 3 year of experience in technical project management
* Knowledge of ISO 13485
* Strong interest and ability to lead and optimize sub-projects with American stakeholders (some travel is expected)
* Interest in resolving technical problems and interdisciplinary teamwork
* Experience and willingness to work in a highly regulated industry
* Familiarity with or strong interest in engineering applications and tools
* Enthusiastic team player with good communication and collaboration skills. Solution-oriented, autonomous, and proactive working style
* Proven experience in laboratory diagnostics and/or service & support, as well as supporting HW and SW, are additional assets
* Working knowledge and fluent in English (written and spoken), and German a strong asset
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