Senior Manager, Manufacturing Engineering
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Job Detail
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Offered Salary 0
Job Description
Position Description
The Senior Manager, Manufacturing Engineering is responsible for assisting the corporation in meeting gross margins requirements by providing and maintaining qualified automation solutions to manual manufacturing operations which increases capacity and lowers costs. The incumbent will be responsible for overseeing the manufacturing engineering department, ensuring the successful execution of projects, and fostering a collaborative and innovative work environment. This role requires strong leadership skills, technical expertise, hands on involvement and the ability to manage multiple projects simultaneously.
Include the following but other duties may be assigned:
– Lead and mentor a team of engineers, providing guidance and support to ensure professional growth and development.
– Oversee the planning, execution and delivery of engineering projects, ensuring they are completed on time, within scope and on budget.
– Responsible for the design, sourcing, validation, implementation and maintenance of manufacturing equipment, resulting in increased cost effectiveness and product quality
– Responsible for the manufacturing operations preventive maintenance
– Responsible for providing manufacturing facility requirements for manufacturing facility redesign and expansion.
– Responsible for managing departmental budget, develop business cases for capital projects
– Manage/ create / approve SOPs documentation and Change Control documentation,
– Manage resource allocation, project prioritization and workload distribution.
– Responsible for setting and implementing equipment validation strategy to satisfy relevant regulatory requirements
– Responsible for ensuring on-going compliance to applicable quality and EHS regulations and standards (e.g., ISO, US FDA, MOD, IVDD, EU-PSHA, OSHA, ).
– The position requires work with potentially biohazardous and/or chemically hazardous materials and the ability to lift and carry 25 lbs.
Position Requirements
– B.SC. or M.S. in Life Science, Engineering, or Business, plus 5 years of experience in a management role in a bio-tech / medical device or a medical device instrument-related organization.
– GMP experience with in vitro diagnostics or medical device industry preferred.
– Lean, Six sigma or related experience preferred
– Expertise in process optimization, automation and lean methodologies to enhance efficiency and reduce waste
– Automated system and PLC experience preferred
Personal Requirements
– Good time management and planning skills.
– Project management
– Knowledge of management principles and strong leadership
– Understanding of financial analysis to ensure decisions made and processed established are cost effective for the
– Understanding of cost estimation, project budgeting and resource allocation to optimize operational efficiency