- Leads best design practices for Innovation, ensuring safety and performance compliance with industry standards
- Ensures timely delivery of comprehensive Design History Files and Risk Management Files to the Sustaining Engineering Team for registrations and audits
- Provides expert technical advice to internal and external contacts, requiring interpretation of complex information internally and factual information exchange externally
- Ensures the continuity of products and processes by assessing feasibility, conducting research, overseeing design and development, and ensuring compliance with customer and non-customer requirements. Manages the transfer to production.
- Provides general engineering direction, coordinates multiple resources to solve complex problems, and leads design reviews. Assigns and reviews action items to drive solutions.
- Makes impactful decisions on the scope of work, with autonomy to propose alternatives while normally following a specified course of action. Ensures short-term decision impacts and compliance with regulatory requirements. Acts as a mentor within the engineering organization
- Up to 20% travel (domestic and international) may be necessary
- Degree in natural sciences (biomedical, engineering, etc.)
- Fluent in English (spoken/written), proficient in German (B2)
- 5 + years experience with compliance to ISO 13485, ISO 14971, ISO 62304, EU MDR and
- with design & development of Class I & Class II Medical Devices
- Direct Experience with Management of EU MDR and FDA submissions and/or deficiencies
- Proven Success as a Change Management Agent and leading through Influence
- Proven project leadership, self-initiative, and proactive technical support. Strong leadership ensures meticulous compliance documentation. Innovative thinking with a significant impact on R&D initiatives
- Front Room Audit Support Experience
- Experience with ALM and/or PLM applications
- See your career like never before with focused growth and development opportunities
- You will get a competitive salary & benefit package
- You have the opportunity for hybrid work
- You will work in a welcoming and inclusive environment with highly qualified colleagues at a market-leading multinational Team
- You can contribute to the quality and compliance of innovative medical solutions
Principal Engineer - Erlangen, Deutschland - Alcon
Beschreibung
At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you'll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.
As a Principal Engineer (m/w/d) supporting the Design Control / New Product Development Team, you will be entrusted to work at one of our locations in Erlangen or in Teltow, Berlin.
In this role, a typical day will include:
WHAT YOU'LL BRING TO ALCON:
NICE TO HAVE:
HOW YOU CAN THRIVE AT ALCON:
Alcon Careers
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