Sr Engineer–Electronic Systems Job in Aliso Viejo 92651, California US
Sr Engineer--Electronic Systems
Building on its heritage of more than 65 years, Alcon, the global leader in eye care, is the second largest division of the Novartis Group with combined pro-forma sales of more than USD 9.4 billion in 2010. The division was formed by Novartis on April 8, 2011, following the closing of the merger between Alcon and Novartis. The new Alcon Division combines the product portfolios, commercialization capabilities, RD and talent of Alcon, CIBA VISION and Novartis Ophthalmics. Today, Alcon has more than 22,000 employees with headquarters in Fort Worth, Texas, U.S.A. Alcon's three businesses - Surgical, Pharmaceutical and Vision Care - meet the diverse needs of eye care professionals and patients offering the widest spectrum of eye care products with operations in 75 countries and products available in 180 markets. For more information, visit www.alcon.com .
Alcon LenSx Inc., is always looking to expand its team with bright and dedicated people. Based in Aliso Viejo, California, LenSx® is focused on providing better outcomes to cataract patients by delivering an all-laser alternative to manual cataract surgery.
Job Summary:
The Systems Senior Manufacturing Engineer, is responsible for sustaining support, product improvements, transition to manufacturing and cost reduction activities. The position is also responsible for review/approval of components and assemblies, as well as technical development of suppliers, including audits and corrective action activities identified through the NCMR or CAPA process.
Essential Duties and Responsibilities:
- To perform this job successfully an individual must be able to perform each essential function satisfactorily:
- Provides manufacturing engineering support of corporate goals. Ensures timely completion of project(s) in accordance with requirements by applying practical timelines and tracking project status.
- Develops, validates, implements, maintains and revises procedures, processes, routings, test specifications, and documentation as required, to ensure in-house manufacturing adheres to current standards of quality and compliance.
- Develops documents and verifies fixtures and tooling and trains manufacturing personnel on the use of new fixtures, or tooling introduced into the manufacturing process.
- Works with cross-functional team to document and implement product improvements, and processes them for release via MQ1 electronic change request software.
- Initiates, investigates and dispositions non-conforming material documentation, generates rework instructions and participates in engineering change control and corrective action process activities as required.
- Drives corrective action and supplier development activities, participates in external audits and works closely with RD, GSCM, Manufacturing and suppliers to resolve supplier issues related to electronic components/assemblies.
- Writes, executes and manages manufacturing and process validation protocols to ensure compliance with cGMP's and ISO 13485 Operations requirements.
Qualification Requirements:
- Functional knowledge of medical device Product Development Process, including transition to manufacturing (process and procedures), manufacturing of Class III medical devices and documentation associated with design specifications and procedures for an FDA-regulated company.
- Strong technical background in medical products (especially complex capital equipment) including, but not limited to, electromechanical component and assembly manufacturing, and performance monitoring.
- Experience and working knowledge of tool/fixture development including software, from documentation of the fixture through drawings/specifications, to work instructions for use of the fixture and Verification or Validation protocols, reports and activities.
- Makes good decisions in a timely manner based upon a mixture of analysis, wisdom, experience and judgment. Is able to make decisions without complete information and under tight deadlines.
- Orchestrates multiple activities at once to accomplish a goal; uses resources effectively and efficiently and is able to adjust in light of change and shift gears comfortably. Works in a scale-up environment where flexibility, adaptation to change and ability to communicate changes is essential.
- Can interface and communicate verbally as well as written with cross-functional personnel and co-workers, including design, manufacturing and quality engineering, supply chain management and supplier representatives. Is willing to be part of a team unit and cooperate in the accomplishment of organizational goals and objectives.
- Is dedicated to meeting the expectations and requirements of internal and external customers. Is productive and efficient in planning and executing work and can work independently, under pressure, meet deadlines and prepare clear and concise reports.
- Is able to work with minimal to no supervision and can communicate with and follow the directions of the Director of Manufacturing Operations to prioritize workload and determine priorities even when subjected to changes in schedule.
- Strong working background in the development of suppliers, resolution of manufacturing issues, implementation of formal corrective actions or product improvements, audits and process capability.
Requirements:
- Minimum of B.S. in Engineering or B.A. in related field(s) strongly preferred plus minimum of 7 years related experience and/or training or equivalent combination of education and experience in the field of medical device manufacturing.
- Requires minimum of three years of experience in an FDA regulated environment, must also have ISO 13485 and/or cGMP regulations knowledge.
- Requires excellent skills in Microsoft Office - Word, Excel and Power Point, skills in Microsoft Project and VISIO ideal. Use of statistical software packages preferred.
Our generous benefits package includes the Novartis Investment Savings 401(k) Plan which provides a company contribution of up to 6%. In addition, after one year of service, employees are eligible for the Alcon Retirement Plan (ARP), to which Alcon contributes 6% of eligible pay. By combining the Company's contributions to the 401(k) and ARP, employees can receive up to 12% of eligible pay from Alcon towards retirement. Alcon also offers a premier level of coverage for medical, dental, vision, life and disability coverage, an on-site fitness center and much more. Consider having all this in a fast paced environment within a stable world-class organization.
