Senior Manufacturing Engineer(Medical/Pharma)-- KAUDC5733235 (Draper)

How you will make an impact: • 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 Organizations 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 • Cleanroom environment experience • 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