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Design Control/Risk Management Principal Engineer

Company: Alcon Pharma
Location: Lake Forest
Posted on: January 12, 2021

Job Description:

Purpose of PositionEnsure efficient application of design control and risk management principles to develop and launch medical device products that are safe and effective, and delight Alcon customers. ResponsibilitiesPlans and executes design control and risk management deliverables in collaboration with project core teams and functional stakeholders in support of project milestones and objectives, consistently with Alcon Quality Management System and Alcon documentation structure, e.g., DHF, Technical File, strategy.Subject Matter Expert on design control and risk management processes, e.g., FDA 21 CFR 820.30 and FDA guidance; European MDD and MDR; ISO 13485 and ISO 14971 and Alcon Quality Manual System responsible for local implementation and influencer of global practices.Responsible for developing Design History Files and Risk Management Files that support effective and efficient global registrations and launches of quality products, e.g., minimize regulatory agencies questions during submission, minimize gaps that may result in audit findings, minimize CAPAs caused by lack of design control discipline.Train, educate and coach core teams and functions and applicable design control and risk management requirements, tools and techniques to optimize design control activities and completeness of deliverables focusing on products that are safe and effective to our users and delight our customers.Champion new processes, tools and IT applications to R&D teams in collaboration with stakeholders to drive improvements. 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.Create value through expert application of design control and risk management principles, e.g., do it right, with simple and elegant solutions to complex problems, and high expectations of quality. Lead systematic approach to risk management (including usability) including championing use of appropriate tools, e.g., FTA, FMEA, Task Analysis, where appropriate, and maintenance of risk management reports and files.Gathers, understands, and analyses input requirements from stakeholders for new medical devices while supporting existing products and service infrastructureSynthesizes all gathered information together with technical and regulatory constraints (including State-of-the art) in order to define a system and its behavior resulting in defining a product/system specification.Determine how systems will be architected and implemented. Provide guidance and leadership to teams as appropriate.Provides guidance in conducting and evaluating Verification and Validation activities so they comply with internal procedures, meet appropriate industry standards and are statistically relevant.Author or co-author technical reports to be included in regulatory submissions.QualificationsBachelor---s Degree or Equivalent years of directly related experience (or high school 13 yrs; Assoc.9 yrs; M.S.2 yrs; PhD0 yrs)The ability to fluently read, write, understand and communicate in English5 Years of Relevant ExperienceProven ability to develop and/or implement advanced processes and techniquesKnowledge of ISO 13485 and ISO 14971 standards, FDA regulations and guidance---s, MDD and MDR applicable to the design and development of medical devicesExperience motivating complex teams cross-functionally without direct reportingOrganizational management of multiple disciplinesInteractions with senior personnel on complex or significant technical matters, often requiring coordination across organizational linesRelocation Assistance AvailableAlcon is an Equal Opportunity Employer and participates in E-Verify. 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, gender identity, 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 email to and let us know the nature of your request and your contact information.Full time

Keywords: Alcon Pharma, Lake Forest , Design Control/Risk Management Principal Engineer, Executive , Lake Forest, California

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