Principal Engineer II, Product Certification at Alcon

Lake Forest, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

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), preferably in EE or similar major
8+ years in medical device products safety compliance evaluations, and/or fully accredited test labs such as UL, CSA, Intertek or Element, etc
5 Years of Relevant Experience
The ability to fluently read, write, understand, and communicate in English
Expert knowledge of IEC 60601-1 3rd Ed (3.1 and 3.2) of medical electrical equipment standards and including particulars & collateral standards
Proven experience in application to EM medical devices
Proven experience in successfully being able to work with cross functional teams
Strong familiarity with EMC test planning and procedures per IEC 60601-1-2 and associated test practices
Working knowledge of ISO 14971 Risk Management for Medical Devices in medical device products safety compliance, and/or fully accredited test labs

Responsibilities

Perform Safety certification test assessments throughout the development lifecycle including early stages to provide the necessary inputs to R&D to drive product development
Support development including planning, communicate periodic status and known risks (with proposed solutions) on the projects to R&D core teams
Capable of performing safety testing of Alcon products in the Alcon safety Lab and external labs
Prepare documentation to execute safety certification activities – Isolation Diagrams, perform Dielectric and Leakage current testing, Construction evaluation using IEC generated test reports forms
Communicate with internal/external labs, technicians, and design engineers to accomplish timely/valuable results at optimal cost (from Quote request to final deliverables)
Collaborate with teams to ensure full execution of identified required testing and review activities needed to ensure product compliance including de-risking product launches through pre-verification test rehearsals
Document and execute all V&V tests compliant to medical device QSR, ISO 13485. Prepare clearly written, accurate, highly detailed Safety verification test plans and test reports
Effectively communicate complex concepts in formal/informal presentations and in technical reports; proven technical writing skills is required (assessed during interview)
Plan and execute Safety testing of electrical equipment and certification for global market access
Ensure compliance with Product Safety testing requirements and procedures per the governing standards and Alcon QMS. Includes ensuring test samples meet production equivalency requirements
Use and ensure maintenance of commonly used safety equipment, and calibration procedures. Provide guidance and requirements to external labs used for certification testing

Skills

Key technologies and capabilities for this role

Safety CertificationDielectric TestingLeakage Current TestingIEC StandardsIsolation DiagramsISO 13485QSR ComplianceV&V TestingTest PlanningLab TestingProduct Compliance

Questions & Answers

Common questions about this position

What is the location for this Principal Engineer II role?

The role is located at Alcon's R&D facility in Lake Forest, CA.

What experience is required for this position?

Candidates need a BS (preferably in EE or similar major) and 8+ years in medical device products safety compliance evaluations.

What key skills are needed for the Principal Engineer II, Product Certification role?

Required skills include performing safety certification test assessments, preparing documentation like Isolation Diagrams and test reports, strong technical writing, knowledge of ISO 14971 Risk Management, and familiarity with EMC test planning per IEC 60601-1-2.

What is the company culture like at Alcon?

Alcon fosters an inclusive culture, recognizes contributions, offers career growth opportunities, and emphasizes innovation, progress, and impacting global eye health.

What makes a strong candidate for this role?

Strong candidates will have proven technical writing skills (assessed during interview), experience with safety testing and compliance standards like ISO 14971 and IEC 60601-1-2, and the ability to communicate complex concepts effectively.

Alcon

Specializes in eye care products and solutions

About Alcon

Alcon specializes in eye care products and vision solutions aimed at improving people's quality of life through better vision. Their product offerings include solutions for cataract surgery, retinal health, and contact lenses. Alcon's products work by utilizing advanced technology and research to provide effective treatments and aids for various eye conditions. What sets Alcon apart from its competitors is its strong emphasis on research and development, ensuring that they remain leaders in the eye care industry. The company's goal is to enhance vision and overall quality of life for individuals while promoting a diverse and inclusive workplace.

Geneva, SwitzerlandHeadquarters

1945Year Founded

IPOCompany Stage

Social Impact, HealthcareIndustries

10,001+Employees

Benefits

Medical, dental, & vision coverage

HSA Medical Plan

PTO

Paid Parental leave

401k

Retirement Plan Company Contribution

Low payroll deductions

Tuition Reimbursement Program

Annual Bonus

Free Family Contact Lens Program

12 Company Paid Holidays

Risks

FDA recall of contact lenses may harm Alcon's reputation and financial standing.

Antitrust case denial could lead to legal challenges and financial penalties.

Innovative competitors like Signal12 threaten Alcon's market share in eye care.

Differentiation

Alcon leads in eye care with a broad product portfolio and global reach.

The company invests heavily in R&D, ensuring cutting-edge vision solutions.

Alcon's commitment to diversity and inclusion strengthens its corporate culture.

Upsides

Acquisition of BELKIN Vision enhances Alcon's glaucoma treatment options with DSLT technology.

Orbis Flying Eye Hospital project boosts Alcon's global presence and eye care standards.

Recognition as a top employer in Singapore attracts and retains top talent.

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