Full Job Description
Objective:
Provide engineering and project management skills in support of the design and development of new processes/equipment, the scale-up and commercialization of new products, the continual improvement of existing technologies, and the optimal performance and troubleshooting of existing operations.
Key Activities/Responsibilities:
• Provide strong engineering skills in support of the scale-up and development of new products and processes. This includes methods, procedures and specifications to ensure a timely transfer to manufacturing.
• Provide strong engineering understanding on continual improvement teams, developing process methods, designing/sourcing equipment, conducting feasibility/developmental trials, executing validation requirements, drafting documents/specifications/drawings, and providing on-the-job training to ensure the effective transfer/start-up of new/refined products/processes.
• Manage equipment and process validations, including creation of the protocol, identification of test requirements, analysis and presentation of results, and creation of the final report, in accordance with internal procedures and external regulations.
• Utilize Lean Manufacturing principles and appropriate tools to drive continual improvement of key operational measures, e.g. yield, cycle time, takt time, inventory, nonconformances, etc.
• Provide engineering support to manufacturing and QA groups to ensure that production requirements are satisfied. Lead investigations pertaining to NC's, CAPA's, complaints, and production troubleshooting
• Prepare presentations and reports, as appropriate, to communicate status of engineering projects, progress towards goals and objectives, future opportunities, and current risks/alternatives to management.
• Support the site in developing, training, and maintaining calibration/preventative maintenance programs and manufacturing process controls.
Qualifications/Training:
• BS degree in Engineering
• 6+ years of experience in an engineering position within a medical device manufacturing organization
• Working knowledge of Lean Manufacturing Principles
• Six Sigma Green Belt Certification a plus.
• Strong mechanical aptitude, oral and written communication, project management, and organization skills required
• Proficient in CAD software, Servo and/or PLC applications and electro-mechanical systems.
• Thorough understanding of GMP/ISO requirements pertaining to medical device manufacturing operations and FDA-regulated quality systems, specifically experience with non-conformances, CAPA's, complaints and change control.
This position may be available in the following location(s): US - Wilmington, MA
For U.S. locations that require disclosure of compensation, the starting pay for this role is between $100,000 and $120,000. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors.
U.S. based employees may be eligible for short-term and/or long-term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation.
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To learn more please read Bausch + Lomb's Job Offer Fraud Statement
Our US Benefit Programs Employee Benefits: Bausch + Lomb
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