Manufacturing Engineer II

Bausch + Lomb•US-MA-Wilmington, MA

About The Position

The Manufacturing Engineer II provides engineering and project management support for designing and developing new processes and equipment, scaling up and commercializing new products, improving existing technologies, and optimizing and troubleshooting current operations. The role supports product and process transfer to manufacturing and works with manufacturing and quality assurance teams to meet production requirements. The engineer manages equipment and process validations in accordance with internal procedures and external regulations, applies Lean Manufacturing principles to improve operational performance, and supports investigations involving nonconformances, CAPAs, complaints, and production issues. The position also supports calibration and preventive maintenance programs and manufacturing process controls at the site. The position may be available in Wilmington, Massachusetts. Applicants must be authorized to work for any U.S. employer; visa sponsorship is not available. The stated starting pay range is $100,000–$120,000. Eligible U.S.-based employees may also receive incentives and participate in benefit programs.

Requirements

Bachelor of Science degree in Engineering.
At least 6 years of experience in an engineering position within a medical device manufacturing organization.
Working knowledge of Lean Manufacturing principles.
Strong mechanical aptitude and oral and written communication, project management, and organizational skills.
Proficiency in CAD software, servo and/or PLC applications, and electromechanical systems.
Thorough understanding of GMP/ISO requirements for medical device manufacturing operations and FDA-regulated quality systems, including experience with nonconformances, CAPAs, complaints, and change control.
Must be authorized to work for any employer in the United States; visa sponsorship is not available.

Nice To Haves

Six Sigma Green Belt certification.

Responsibilities

Support the scale-up and development of new products and processes, including developing methods, procedures, and specifications for timely transfer to manufacturing.
Contribute engineering expertise to continual improvement teams by developing process methods; designing or sourcing equipment; conducting feasibility and developmental trials; executing validation requirements; preparing documents, specifications, and drawings; and providing on-the-job training for transfer and start-up of new or refined products and processes.
Manage equipment and process validations, including developing protocols, identifying test requirements, analyzing and presenting results, and preparing final reports in accordance with internal procedures and external regulations.
Apply Lean Manufacturing principles and appropriate tools to improve operational measures such as yield, cycle time, takt time, inventory, and nonconformances.
Provide engineering support to manufacturing and QA groups to help ensure production requirements are met.
Lead investigations related to nonconformances, CAPAs, complaints, and production troubleshooting.
Prepare presentations and reports to communicate engineering project status, progress toward goals and objectives, future opportunities, and current risks or alternatives to management.
Support site development, training, and maintenance of calibration and preventive maintenance programs and manufacturing process controls.