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Job Description
Job Summary (30 words): Technical leader for engineering projects and project management of new medical device manufacturing systems with a strong focus on innovation and quality.
Bausch + Lomb, a leading global eye health business, is solely focused on making people see better to live better. The company has a 40-year track record of growth and diversification in Waterford, Ireland's oldest city.
Key Responsibilities:
- Technical leadership of engineering projects and project management for new medical device manufacturing systems.
- Project Management responsibilities include leading multi-disciplined, cross-functional teams to deliver stated project objectives within cost and time requirements.
- Innovate and drive continual improvement to increase systems' reliability, increase manufacturing volumes and decrease cost.
- Provide technical support to Manufacturing and Process Engineering groups.
- Ensure the appropriate cutting-edge technology is in use where appropriate.
- Demonstrate proficiency in development and implementation of business improvement.
- Demonstrate skills of analysis to identify, quantify and justify improvement opportunities.
- Work with internal resources and external systems vendors to ensure successful technology development through to manufacturing validation.
- Manage project schedules to ensure work is assigned and completed on time and within budget.
- Create documentation such as User Requirements Specifications, Validation Documentation, Test Scripts etc.
- for projects.
- Liaise with QA and Operations to successfully validate equipment and systems to industry benchmark standards.
- Keep abreast of technical innovation in automation technologies.
- Provide manufacturing and technical support, risk identification, mitigation and management.
- Develop and implement new technologies and systems to support R&D projects.
- Provide training support, comprehensive systems documentation packages and preventative maintenance procedures for systems applications.
- Create and adhere to project schedules and budgets in line with overall program goals.
- Manage project scope to customer expectations; manage and approve scope changes.
- Communicate project information to all stakeholders (across many sites).
- Manage project communications and performance tracking metrics.
- Identify, manage and mitigate project risk.
- Identify, manage, track and resolve project issues.
- Interface with internal and external customers and vendors.
- Demonstrate leadership skills to engage team members.
- Demonstrate team building skills with motivated team members working well together.
- The job will require travel to global locations as project mix dictates.
Requirements:
- Education: Bachelor's/ Master's Degree in Engineering or other relevant technical equivalent.
- Advanced degree desired.
- Experience: 10+ years' experience in process automation and equipment build with experience in design, build, debug and systems integration of custom built systems and medical products.
- 3+ years project management experience.
- Extensive hands-on experience with medical device and/or pharmaceutical production required (c GMP / FDA regulated environment).
- Experience desired with automated precision material handling, high-speed cartoning and machine vision systems.
- SPC, DOE, statistical analysis, machine vision fundamentals and Project Management Institute certification a plus.
- Specialized Training in the following areas would be advantageous: ISO-9000, GAMP, Minitab, Solidworks, Auto CAD, Microsoft Project.
- Self-directed, excellent communication skills on technical subjects.
- Ability to form relationships with stakeholders from many sites and work within cross functional teams.
- Project Management Institute PMP Certificate and Six Sigma (green/black belt) a plus.
- Bausch + Lomb is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates.