Principal Engineer, Design Control NPD

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us?

This role is part of Alcon's Research & Development function, a team that innovates boldly and delivers new products and services to help revolutionize the eye care industry, advance optimal patient outcomes and help people see brilliantly.

The Principal I, Research & Development Process & Product Design (Science/Tech/Engineering Path), is primarily responsible for supporting customer business through innovative science and solutions. You will apply advanced scientific principles to solve problems and drive innovation, offering technical advice to junior professionals. This role will also be responsible for planning, directing and implementing all aspects of design and development of products. Investigates and evaluates the conceptualization of new methodologies, materials, processes, or products from initial design to market release. Monitors documentation throughout product life cycle. You will be providing Design Control Engineering tactical expertise to develop Alcon innovative complex electro-mechanical equipment and software systems.

In this role, a typical day will include:

• Contribute to research-driven product development, focusing on design optimization, material characterization, and advanced computational modeling

• Evaluate product performance through in-depth analysis, using empirical and theoretical data to refine design specifications

• Support regulatory submissions, data validation efforts, and scientific research to ensure product safety and efficacy

• Engage in cross-disciplinary collaboration to integrate novel research findings into product development strategies

• Responsible for developing Design History Files (DHFs) and Risk Management Files (RMFs) 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.

• Acts as Subject Matter Expert (SME) on design control and risk management processes, including FDA 21 CFR 820.30, FDA guidance, European MDD and MDR, MDCGs, ISO 13485, ISO 14971, IEC 62304, IEC 60601 and Alcon Quality System. Responsible for local implementation of these processes and influencer of global practices.

• Plans and owns, or drives execution, of quality and value-add design control and risk management deliverables in collaboration with project core teams and functional stakeholders, in support of project milestones and objectives.

• Design Control deliverables ownership may include, but not be limited to, Design Plans, Design Inputs, Traceability Matrices, Design Verification and Validation Plans and Summary Reports, Design Review Reports.

• Leads Design Phase Reviews.  Collaborates with R&D Lead and rest of Core team to assemble design review material that “tells the story” of the design, makes relevant conclusions, provides evidence that the development was executed according to the design plan and facilitates the independent review of the design.

• Leads systematic approach to requirement management, including traceability of design inputs to design outputs, design verification and validation and traceability to risk management.

• Leads systematic approach to risk management (including usability), from planning, to identifying and assessing risks by championing use of appropriate tools (e.g., Hazards Analysis, FTA, FMEA, Task Analysis), driving identification and implementation risk controls, benefit-risk analyses, consideration of State of the Art (SotA) and disclosure of residual risks.   Works with the technical and medical experts to drive the process.  Responsible for authoring and updating Risk Management Reports.

• Coaches teams on effective and efficient application of the design control and risk management processes, including usability, product security and software development, establishes best practices and disseminates them across the organization.

Experience:

• Medical device product development (electrical, mechanical, optical, software)

• Design control for medical devices development (21 CFR 820.30, ISO 13485, MDD/MDR)

• Risk Management for medical devices (ISO 14971)

• SW development for medical devices (IEC 62304), including SiMD and SaMD

• Medical electrical equipment basic safety & essential performance IEC 60601 series

• Usability Engineering for medical devices (IEC 62366-1)

• Product Security for medical devices

Licenses and Certifications (Preferred)​:

• Medical Device Risk Management / ISO 14971

• Medical Device Design Control (21 CFR 820.30, ISO 13485, MDD/MDR)

• Agile Development / Scrum Master

• Six Sigma

What You'll Bring to Alcon:

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+0 yrs) 

• The ability to fluently read, write, understand, and communicate in English

• 5 Years of Relevant Experience

How You Can Thrive at Alcon:

• Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!

• Alcon provides robust benefits package including health, life, retirement, flexible time off, and much more!

• Travel Requirements: 0-5%

• Relocation assistance: Yes

• Sponsorship available: No

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Alcon 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 alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.