Senior Manufacturing Engineer; Medical​/Pharma KAUDC

Responsibilities

• Identifying and ensuring implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensuring equipment, tools, fixtures, etc. are up to standards.
• Developing complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyzing results, making recommendations, and developing reports.
• Analyzing and resolving complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).
• Developing training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.
• Leading and establishing project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).
• Overseeing manufacturing support tasks; giving instruction to technicians on conducting tests; training technicians and providing feedback; and coordinating technician work.
• Collaborating across sites and cross functional teams (R&D and commercial).
• Coordinating manufacturing builds and raw material allocations.
• Leading process validations (IQ, OQ, PQ).
• Supporting documentation for the team.

What you’ll need (Required):

• A Bachelor's degree in Engineering or Scientific field with 4 years of previously related industry experience OR Master’s degree in Engineering or Scientific field with 3 years of previously related experience Required.

What else we look for (Preferred):

• Proven expertise in usage of MS Office Suite including MS Project; CAD experience preferred
• Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
• Strong organizational skills with the ability to manage complex projects/tasks
• Good adaptability in changing projects, directions, and priorities
• Good time management skills to ensure timely completion of tasks
• Ability to drive tasks with minimal supervision; self-starter
• Basic understanding of statistical techniques
• Previous experience working with lab/industrial equipment preferred
• Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Strong problem-solving, organizational, analytical and critical thinking skills
• Substantial understanding of processes and equipment used in assigned work
• Good leadership skills and ability to influence change
• Knowledge of and adherence to Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Knowledge of applicable FDA regulations for medical device industry
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast-paced environment
• Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
• Understanding of Phase-gate product development
• Medical device or regulated industry experience
• Understanding of design requirements documentation, risk management plans, inspection criteria, test method development and validation activities
• Knowledge of manufacturing line design
• Knowledge of process creation and process improvement
• Knowledge of process and design transfer activities
• Understanding/knowledge of Design for Manufacturing (DFM) principles