Technical Product Lead - Hardware Diagnostics Systems - RZ
Role details
Job location
Tech stack
Job description
Within an international and highly networked setup, the PCR Hardware Development organisation - including the Instrument Product Care team - is responsible for the long-term maintenance and continuous improvement of complex diagnostic platforms that combine hardware, software and consumables.
In the role of Technical Product Lead (Hardware), you will be an integral part of a cross-functional product team supporting diagnostic instruments used in Nucleic Acid Purification, PCR and Sequencing. Your focus lies on product life cycle activities, technical decision-making and coordination with internal experts as well as external development and engineering partners. You will act as a technical authority, aligning engineering solutions with business and product strategy in close collaboration with Product Management at Roche., Technical & Project Leadership
- Take ownership of the hardware product care scope as technical lead and steer work package planning, execution and prioritisation together with line management
- Drive engineering change activities across the product life cycle
Budget, Cost & Progress Control
- Manage and control development budgets related to hardware product care and CoGP
- Track technical progress and ensure transparency towards key stakeholders
Design Control & Specifications
- Define, maintain and approve technical concepts, requirements and specifications
- Ensure alignment with internal standards and external development partners
Quality, Reviews & Change Management
- Lead and moderate technical reviews and redesign discussions (incl. PCBA and firmware topics)
- Approve technical changes and actively contribute to Design Quality Management (DQM) activities
- Negotiate technical solutions with business and product representatives
Verification & Risk Management
- Oversee planning, execution and documentation of verification activities together with Test Managers and Product Owners
- Actively manage technical and project-related risks and contribute to Product Risk Assessments
System Integration & Interfaces
- Support system integration and design V&V activities
- Resolve interface issues in collaboration with architects and system engineers
Stakeholder & Partner Coordination
- Manage external suppliers and engineering partners
- Align closely with internal functions such as Business, Operations, Supply Chain and Development
- Establish clear and efficient communication structures across Europe, the USA and Asia
Requirements
- Degree in engineering or life sciences (e.g. mechanical or electrical engineering with life science focus) or equivalent professional experience as a Technical Project Leader
- At least 3 years of experience in technical project management
- Solid knowledge of ISO 13485 and regulated development environments
- Proven experience working in a highly regulated industry
- Strong motivation and capability to lead technical sub-projects with US-based stakeholders (incl. travel)
- Fluency in English (written and spoken); German is a strong advantage
Additional Assets
- Background in laboratory diagnostics and/or service & support environments
- Experience supporting both hardware and software topics
- Familiarity with engineering tools or strong willingness to learn
Personal Attributes
- Structured, solution-oriented and proactive working style
- Strong communication and negotiation skills
- Team-oriented mindset with the ability to work autonomously in complex environments