Description:Design, develop, modify and qualify processes and methods for the manufacturing, 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:technical writing, equipment setup, iq oq pq, catheter, fda, iso 13485Top Skills Details:technical writing,equipment setup,iq oq pq,catheterAdditional Skills & Qualifications:Bachelor of Engineering with working knowledge of engineering principles and 5 years of experience Experience with Class 3 Devices (sterile medical devices); catheter manufacturing engineering experience preferred. Demonstrated utilization of Design for Manufacture/Assembly and Design for Test methodologies highly desirable.Experience Level:Expert LevelAbout Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.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
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] (%[email protected]) for other accommodation options.