Description:

　　• Be actively involved in selecting, sourcing, testing and approving materials to achieve specifications and reliability requirements.

　　• Design, develop, modify and qualify processes and methods for the manufacture, molding and utilization of metallic, plastic, composite and other materials in construction and production of hardware, electronic components and structures.

　　• Set-up and qualify manufacturing and test equipment for production line duplication.

　　• Determine equipment parameters and analyze the outputs for all the manufacturing, test and packaging equipment.

　　• Develop and execute test methods including fixturing and validate test methods for product evaluation.

　　• Create ECOs’ (Engineering Change Orders), DCOs' (Document Change Requests) Plans, Protocols and Reports under broad direction.

　　• Create and / or update production work instructions.

　　• Support qualification of manufacturing equipment changes / process / testing and inspection, and ensure compliance to quality standards through the creation and execution of protocols.

　　• Create and maintain the technical documentation for building a complete device master record.

　　Skills:

　　design for manufacturing, engineering change orders, catheter, iso 13485, fda

　　Top Skills Details:

　　design for manufacturing, engineering change orders, catheter

　　Additional Skills & Qualifications:

　　• Bachelor of Engineering with working knowledge of engineering principles and at least 5 years’ related experience and/or training in sustaining/manufacturing engineering in the medical device industry.

　　• Demonstrated medical device design experience required specifically with sterile medical devices; catheter manufacturing engineering experience preferred.

　　• Effective Communication skills.

　　• Demonstrate good approach to problem solving and project management.

　　• Knowledge and Interpretation of FDA guidelines and ISO 13485 requirements.

　　• Demonstrated utilization of Design for Manufacture/Assembly and Design for Test methodologies highly desirable.

　　Experience Level:

　　Expert Level

　　Diversity, Equity & Inclusion

　　At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

　　Hiring diverse talent

　　Maintaining an inclusive environment through persistent self-reflection

　　Building a culture of care, engagement, and recognition with clear outcomes

　　Ensuring growth opportunities for our people

　　Actalent is an equal opportunity employer.

　　About Actalent

　　Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.