Job Description
Technical Lead Systems Engineer In Vitro Diagnostics (IVD)
Location: Zurich
Job Type: FullTime 80100
About Us:
My client are leading innovator in the medical technology sector dedicated to improving patient care through cuttingedge diagnostic solutions. Our team is passionate about developing stateoftheart in vitro diagnostic devices that are both accurate and reliable.
Position Overview:
We are seeking a highly skilled and motivated Technical Lead Systems Engineer to join our dynamic team. The successful candidate will lead the design development and integration of complex IVD systems. This role requires a deep understanding of both the technical and regulatory aspects of IVD device development.
Key Responsibilities:
- Lead the systems engineering efforts for IVD product development from concept through commercialization.
- Develop and manage system requirements architecture and design documentation.
- Oversee the integration of hardware software and assay components into cohesive IVD systems.
- Collaborate with crossfunctional teams including biology chemistry software and hardware engineering to ensure seamless product development.
- Conduct risk assessments and develop mitigation strategies.
- Ensure compliance with relevant regulatory standards including ISO 13485 and FDA 21 CFR Part 820.
- Manage system verification and validation activities.
- Provide technical leadership and mentorship to junior engineers.
- Stay uptodate with advancements in IVD technologies and regulatory changes.
Qualifications:
- Bachelors or Masters degree in Systems Engineering Biomedical Engineering Electrical Engineering or related field.
- Minimum of 5 years of experience in systems engineering with at least 3 years in IVD product development.
- Strong understanding of IVD development processes including design control risk management and regulatory requirements.
- Proven experience with system integration and troubleshooting complex IVD systems.
- Excellent project management and leadership skills.
- Strong analytical and problemsolving abilities.
- Effective communication skills both written and verbal.
- Experience with modeling and simulation tools is a plus.
- Fluent in English and German
What We Offer:
- Competitive salary and benefits package.
- Opportunity to work on cuttingedge technology that makes a real difference in patient care.
- A collaborative and innovative work environment.
- Professional development opportunities.
How to Apply:
Get in touch with Christopher Boateng at or call