•The Principal Engineer in Design Control strategically plans and executes design control activities in collaboration with project core teams and functional stakeholders.
•Design History Files and Risk Management Files that support global registration and launch of quality products for Alcon Surgical R&D.
•Expert in design control and risk management processes including FDA 21 CFR 820.30 and FDA guidance; European MDD and MDR; ISO 13485 and ISO 14971 and associated tools.
•Understand, interpret and educate project teams on design control requirements, risk management techniques and Alcon product development processes.
•Plan, coordinate, execute and deliver quality, value-added project Design Control deliverables including Design Plans, Design Input, Traceability Matrices, Design Verification and Validation plans and Summary reports, Design Reviews and Design History File.
•Plan, coordinate, execute and deliver quality, value-added project Risk Management deliverables including risk management plan, device, process and usability risk assessments (FMEA, FTA, Task Analysis), risk management report and risk management files.
•Deliver complete Design History Files and Risk Management Files to support efficient product registration activities. Present and answer project design control questions during audits.
•Coach and mentor junior engineers in design control and risk management processes and tools Own one or several processes, SOPs and/or systems and implement improvements with stakeholders within change management framework.
•Resolve findings and develop, track, close CAPAs in partnership with QA owners.
Alcon is an Equal Opportunity Employer and participates in E-Verify. As part of the Novartis Group of Companies, Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to firstname.lastname@example.org and let us know the nature of your request and your contact information
alrpo EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Minimum requirements Minimum Qualifications-
•Bachelor's degree in Engineering
•6 years directly related experience
•Proficiency in the English Language
• Advanced degree in engineering
• Demonstrated experience with ISO 14971
• DFSS (Design for Six Sigma) experience
• Demonstrated experience in new product development (focus on Design Control and/or Risk Management) in the Medical Device and/or Pharmaceutical industries
• Ability to navigate "big picture" items and project execution details simultaneously
A little about us:
As the global leader in eye care, Alcon develops and manufactures innovative medicines and devices to serve the full life cycle of eye care needs.