The Engineering / NPI Engineer will be the key person to support the product improvements %28parts and processes%29 in-house and outside at the company vendors. this role will be in charge for cost-effective, quality improvements and rump up the production volume.
Essential Duties And Responsibilities:
• Coordinate with R&D and production departments to develop and implement Manufacturing Requirements.
• Assist Manufacturing department and manage communication across all departments including integration of all products according to product lifecycle to identify resources and evaluate the impact on manufacturing processes for new products or major engineering changes %28ECOs%29.
• Develop product test plans, risk assessments and production tests according to manufacturing process instructions.
• Ensure compliance with all ECO /QA procedures and work instructions.
• Work with design engineering and assist in the transition of design prototypes into cost-efficient and high-volume products.
• Design new manufacturing process requirements and associate guidelines.
• Analyze and recommend corrective action in case of any design failure before releasing it to mass production.
• Responsible for DFM, DFA, and DFT activities in early project %28design%29 stages.
Qualifications:
• B.Sc. in mechanical engineering
• At least 4 years of hands-on experience with R&D / NPI / Engineering %28in the medical device- big advantage%29.
• Strong foundation in medical devices production technologies such as laser cutting and welding, electro-polishing, machining, milling, etc. %28catheters re-flowing and Plastic injection molding are an advantage%29.
• Experience in manufacturing with sub-contractors.
• QA and RA basic knowledge and process %28CAPAs, MRBs, SCARs%29 in Pharma or Medical Device Company are an advantage
• Technical understanding is a must.
• Highly skilled at Solidworks.
• High level English skills %28writing and speaking%29.
