The Manufacturing Engineer will have experience with various manufacturing and assembly equipment and processes. They will be responsible for the assembly line and production. Working across teams such as R&D and Quality, this role will be responsible for developing and implementing manufacturing processes and procedures to ensure efficient manufacturing and the highest quality and safety.
Duties/Responsibilities
Oversee the production line(s) and production efforts.
Manage and maintain clean room operations.
Develop and maintain process documentation, including standard operating procedures, work instructions, and process flow diagrams.
Maintain knowledge of design prints and approvals to ensure compliance and adherence to presented design prints.
Design and develop manufacturing and procedures for medical device production.
Collaborate with R&D on design changes, approvals and implementation.
Develop and maintain detailed manufacturing plans, schedules, and budgets to ensure timely delivery of products.
Conduct process improvement projects to optimize efficiency, reduce costs, and improve quality.
Collaborate with cross-functional teams including design, quality, and production to ensure successful product launch.
Perform root cause analysis and implement corrective actions to resolve production issues.
Stay up to date on industry trends, technologies, and regulations related to medical device manufacturing.
Required Skills/Abilities
Demonstrated ability to manage complex medical device components.
Familiarity with quality standards such as ISO 13485 and FDA regulations.
Strong problem-solving and analytical skills.
Excellent communication and teamwork skills and the ability to work cross-functionally.
Ability to work independently, under pressure, and to handle multiple projects and tight deadlines simultaneously.
Knowledge of FDA Good Manufacturing Practices, ISO 13485 and 14971, 510k and Standards within Medical Devices.
Has experience in working in high performance organizations and fostering a positive culture with a high degree of accountability and integrity.
Ability to concisely communicate status, needs, forecasts, risks, and timelines effectively to executive team and all levels of the organization (one-on-one and large groups).
Strategic and critical thinker with the ability to analyze, understand and effectively communicate technical material to all levels of the organization.
Education and Experience
Bachelor's degree in mechanical, industrial, or manufacturing engineering, or related field.
Minimum 3 years of experience in assembly line development and management.
Strong knowledge of manufacturing processes, equipment, and tooling.