Sr. Engineer II, Product Certification at Alcon

Lake Forest, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Bachelor’s Degree in Electrical Engineering (EE) or similar major (or equivalent: high school +10 yrs; Assoc.+6 yrs; M.S.+0 yrs)
4 years in medical device products safety compliance evaluations, and/or fully accredited test labs such as UL, CSA, Intertek or Element
Strong 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 working with cross functional teams
2+ years of relevant experience
Ability to fluently read, write, understand and communicate in English
Working knowledge of ISO 14971 Risk Management for Medical Devices in medical device products safety compliance
Strong familiarity with EMC test planning and procedures per IEC 60601-1-2 and associated test practices
Proven technical writing skills

Responsibilities

Conduct circuit analysis, system validation, and performance testing for medical devices
Enhance electrical designs and resolve technical issues
Ensure compliance with regulatory and safety standards
Perform safety certification test assessments throughout the development lifecycle, including early stages, to provide inputs to R&D
Support development including planning, communicate periodic status and known risks (with proposed solutions) to R&D core teams
Perform safety testing of Alcon products in the Alcon safety Lab and external labs
Prepare documentation to execute safety certification activities – Isolation Diagrams, 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
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, including 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

Circuit Analysis

System Validation

Performance Testing

Safety Certification

Dielectric Testing

Leakage Current Testing

IEC Standards

Regulatory Compliance

Medical Devices

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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