Manufacturing Engineer II

Bausch + Lomb•IE - Waterford, MI

5h•Onsite

About The Position

The manufacturing engineer will analyse, control and implement systematic and strategic improvement actions and projects to achieve daily, weekly and monthly KPIs related to Manufacturing Equipment throughput performance and reliability. They will resolve technical and quality issues using appropriate troubleshooting techniques, integrating and coordinating cross-functional teams to meet site safety, quality, delivery and cost goals with continuous improvement integrated into daily activities. The Manufacturing Engineer shall: Clearly understand and align all activities to the overall plant strategy and Enterprise Excellence (CLEAR Vision) systems. Ensure processes and procedures follow relevant regulations e.g. FDA 21 CFR Part 820, GMP, EHS&S, Global Policy, ISO, EN, etc Present, where appropriate, technical data to internal/external audit and inspection groups. Evaluate potential competitive advantage process improvements and implement effective technical/system solutions by leading process improvement projects and managing associated CAPEX. Drive product and process improvements/developments Encourage and foster teamwork within site support functions, coach and mentor team to build capability.

Requirements

Level 8 Engineering Degree – preferable in Mechanical Engineering discipline
5+ Years relevant experience in a highly automated, regulated medical device/pharmaceutical environment
Prior experience of strategic prioritisation and championing critical process issues and continuous improvement through data analysis & Lean/Six Sigma methods
Excellent ability to contextualise and communicate work completed and future direction
Experience of developing a working knowledge of electrical, mechanical, pneumatic software controls, and automated vision systems
Project Management Qualification & Vendor Management experience expected
Prior experience of Project leadership including team building, training and mentoring

Responsibilities

Track and report on daily, weekly and monthly KPIs of specific manufacturing equipment with respect to Throughput, Yield and Reliability.
Identify opportunities with respect to KPI’s and lead programs for systematic and strategic improvements over short, medium and long-term horizons
Support Shift Leads and Area Manager through the provision of Line support to resolve quality and technical issues using appropriate troubleshooting techniques.
Develop, optimise, implement and coordinate planned maintenance and calibration procedures for equipment.
Monitor, identify & source appropriate spare parts.
Provide technical core competency support, including training to operations and maintenance personnel on an as-needed basis, including possible off-hours, remote and onsite coverage rotation.
Analyse trends to identify improvements and optimisation of manufacturing process and procedures.
Coordinate cross functional teams to manage process change through the implementation of new techniques, equipment and process controls.
Promote & Engage Lean Manufacturing & Visual Management concepts within the Value Stream and continuously improve the performance of the process, demonstrate ability to use statistical analysis in relation to review of system yields to identify issues.
Maintain compliance to GMP’s, GDP & implement improvements within the Quality System under change control.
Own, track and report on status of NC’s, CAPAs, Change Controls, and projects related to the Engineering function.
Develop relevant work instructions and SOPs.
Writing/executing process and equipment engineering studies and protocols.
Assist with close out actions arising from Audits, Risk Assessments etc.
Drive a right first-time culture, identify and eliminate repetitious automated machine failures.