Assist in the evaluation of the manufacturing processes by designing and conducting research; applying knowledge of product design, fabrication, assembly, tooling, and materials; conferring with equipment vendors; soliciting observations from operators
Involvement with the engineering team for identifying the most effective production process and guidelines
Develop manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; conferring with equipment vendors
Assist in Improving manufacturing efficiency by analysing and planning workflow, space requirements, and equipment layout
Assure product and process quality by designing testing methods; testing finished- product and process capabilities; establishing standards; confirming manufacturing processes
Provide manufacturing decision-making information by calculating production, labour, and material costs; reviewing production schedules; estimating future requirements
Prepare product and process reports by collecting, analysing, and summarizing information and trends
Provide manufacturing engineering information by answering questions and requests
Keep equipment operational by coordinating maintenance and repair services; following manufacturer's instructions and established procedures; requesting special service
Complete design and development projects by training and guiding technicians
Maintain professional and technical knowledge by attending informational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.
Implementation and integration of automation systems
Production scale-up from manual to semi-automated and fully automated solutions
Design verification and validation per ISO 13485
Requirements:
BS in Mechanical Engineering, Industrial Technology, or other relevant Engineering field
Working knowledge of 13485:2016
8+ years Engineering experience within relevant industry experience with bachelor's degree, 6 years with advanced degree; or 12 years equivalent experience
Experience with medical device manufacturing processes qualification (IQ/OQ/PQ)
Product manufacturing, inspection, and testing experience
All development activities will meet or exceed ISO 13485 design control and risk assessment requirements
High level problem solving, and reasoning skills
Experience with product development processes and project management skills
Experience in production support and/or process development
Experience with statistics, Statistical Process Control and DOE techniques
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