Mechanical Engineer Ii

Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world-from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better. 

Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing, and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future. 

Objective: 

The Mechanical Engineer II, R&D is expected to be a key individual contributor of mechanical design expertise for projects involving the development and/or maintenance of B+L's ophthalmic surgical devices. The individual provides a broad spectrum of medical device product development services throughout the product life cycle from conceptual design to end of life.  This position is a hybrid of other specialized R&D department roles such as design engineering, test engineering, systems engineering, design compliance, and technical writing. The qualified individual is expected to be flexible and adaptable to contribute in any of these areas or to focus in a particular one to accommodate the needs of the business.

A core responsibility is to provide front-line technical expertise across B+L's product value streams to rapidly investigate, troubleshoot, and determine the root cause of problems identified through various product life cycle monitoring systems. They identify, prototype, and evaluate the feasibility of potential technical solutions to problems, and they propose viable design or process changes for production implementation. They act as the primary technical contributor for change projects to implement proposed design or process changes. They author, review and approve design input requirements, engineering drawings, FMEAs, and other design and risk compliance documentation. They author test cases, develop test beds as necessary, and lead re-verification and re-validation activities.  They ensure that design transfer and production implementation of the changes is effectively completed.  They provide post-production technical assessments to inform decisions relative to the acceptability of non-conforming parts, as required.  They may apply a broad knowledge of Mechanical Engineering principles to design new products for ophthalmic surgery for any part of the new product development cycle. They may further provide project coordination and leadership for select development activities involving B+L surgical equipment, packs, handpieces, or single use accessories.

Responsibilities:

• Performs comprehensive engineering activities to support new product development, product improvement, and maintenance of business projects.
• Leads assigned troubleshooting, design change development, and new product development activities.
• Responds rapidly to emerging signals of potential problems; authors and manages the resolution of associated problem reports. 
• Conducts measurements, field observations, bench tests, competitive analysis, engineering modeling, and related experiments to determine the root causes of product or process related anomalies. 
• Performs statistical data analysis; authors documents and records to define the results of such activities. 
• Researches, develops, and modifies design input requirements as required to affect design changes and/or to facilitate new product designs. Defines traceability between design inputs and other design control and risk management elements.
• Innovates concepts for design changes or new products based on design inputs and technical data. Creates 3D Solid Works models and 2D prototype drawings for component parts and assemblies.
• Reviews and modifies design related failure mode analyses, DFMEAs. 
• Acquires parts and assemblies to facilitate prototyping of new designs and design change concepts.
• Collaborates with procurement, supplier quality, and both internal and external manufacturing entities to qualify pilot fabrication and assembly processes.
• Designs and qualifies customized test beds for bench studies and/or design verification.
• Authors test plans, test methods, test protocols, and test reports, often based on review/enhancement to previously applied methods.
• Provides supporting justifications and assessments to facilitate the adoption of existing data in lieu of new testing based on the scope of a proposed design change.
• Represents the R&D function during comprehensive design reviews for supported design changes. 
• Acts as an independent reviewer for design changes supported by other teams. 
• Collaborates with personnel from marketing, manufacturing, and quality to verify the effectiveness of design changes.  
• Communicates technical information in the form of reports and presentations.

Requirements:

• Bachelor's Degree in Mechanical Engineering or Biomedical Engineering. 
• Minimum of 3 years of experience involving medical device development and manufacturing in a GMP environment per ISO 13485 and CFR 821.   
• Minimum 5 years of new product development experience involving mechanical/electro-mechanical devices.
• Experience creating electro-mechanical designs using Solid Works, Autodesk Inventor, or equivalent software.  
• Experience creating engineering drawings, specifications, reports, and other engineering or manufacturing documentation.
• Expertise in mechanical design and tolerance analysis.  
• Good working knowledge of MS Office tools, analytical tools, project management tools, ERP systems.  

Preferred Qualifications:

• Medical device or equipment design and/or change management.  
• Medical device design control and risk management expertise.
• Working knowledge of GD&T. Design for six sigma green belt or equivalent certification.
• Specialized training/application of root cause and problem solving methods (Design of Experiments, Fishbone, 5-Why, TRIZ, etc.).
• 5 or more years of product design experience involving designing and/or testing of electro-mechanical medical equipment or accessories.
• Experience with developing functional hardware designs using 3D software tools.  
• Design of products fabricated using diverse manufacturing processes such as milling, turning, EDM, laser welding/cutting, injection molding, ultrasonic welding, surface coatings, heat treatments, chemical treatments, sheet metal fabrication, tube forming, adhesive bonding, and automated assembly.  
• Heavy experience with preparing test methods, protocols, and reports for use in highly controlled and/or regulated verification activities.
• Substantial history of collaboration with manufacturing, quality, regulatory, and commercial groups.
• Demonstrated history of innovation as demonstrated by patents and successful product introductions.

We offer competitive salary & excellent benefits including:

• Medical, Dental, Eye Health, Disability and Life Insurance begins on your hire date
• 401K Plan with company match and ongoing company contribution
• Paid time off - vacation (3 weeks - prorated upon hire), floating holidays and sick time
• Employee Stock Purchase Plan with company match
• Employee Incentive Bonus
• Tuition Reimbursement (select degrees)
• Ongoing performance feedback and annual compensation review

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.
To learn more please read Bausch+Lomb's Job Offer Fraud Statement.

Our Benefit Programs: https://www.bausch.com/careers/benefits/

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.