Compunnel Inc. · 20 hours ago
Senior Manufacturing Engineer-- KAUDC5733235
Compunnel Inc. is seeking a Senior Manufacturing Engineer to optimize and improve manufacturing processes through engineering methods. The role involves developing experiments, resolving manufacturing issues, and leading project plans while collaborating with cross-functional teams.
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
Qualification
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
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
Company
Compunnel Inc.
Compunnel Inc. is where AI-native solutions meet human ingenuity, helping enterprises reimagine talent, technology, and growth.
H1B Sponsorship
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Funding
Current Stage
Late StageCompany data provided by crunchbase