Entry Level Manufacturing Engineer

Manufacturing Engineer

Quality Engineer

Fast Growing Medical Implant and Surgical Instrument Manufacturer in the greater San Diego area seeks entry level manufacturing engineer to join its expanding manufacturing and quality organization.   Great opportunity for recent industrial engineering, manufacturing engineering, or mechanical engineering grad with an interest in the development of medical device products.  Ideal candidates will have a high GPA and applicable internship experience. Outstanding benefits package that is consistently recognized as one of the best on the market. Excellent long term growth potential and career track.

 



Primary Function of Position:

The successful candidate will:apply his/her manufacturing engineering experience and/or education to the succesful development and manufacture of novel surgical instruments and implants for surgical application. support development efforts and play a key role in transfer to manufacturing while optimizing reliability, serviceability, manufacturability, capacity, and cost. excel in a high-energy team environment and be capable of making careful, sound decisions when faced with the time pressures typical of new product development and manufacturing.

Position Roles and Responsibilities:

Specific responsibilities for this Manufacturing Engineer position include:Evaluate and challenge surgical instrument designs for technical merit, reliability, serviceability and manufacturability. Provide change proposals and participate in change actions. Manage the material configuration of new surgical instruments as they are developed and moved into production. Assist design engineers with material procurement steps and supplier communication. Participate in the assembly of instruments in order to gain experience with designs and to support testing requirements. Support test engineers in verification and validation activities. Troubleshoot and resolve design and manufacturability issue Develop formal manufacturing process instructions, including test procedures Design, build, document and qualify surgical instrument assembly/test fixtures and equipment. Approve design releases to manufacturing, review engineering documentation, provide vendor and in-house DFM inputs. Review/approve and determine impact of ECOs from manufacturing and field perspective. Assist in creation/update and maintenance of efficient manufacturing assembly line, specifying and/or refining BOMs and detailed work instructions. Provide training and support to production technicians. Takes responsibility for maintaining compliance with medical device quality system including corrective action closure, discrepant material dispositions and ECO implementation. Interface with technicians, product development, planning, purchasing, regulatory, inspection, customer support and clinical marketing organizations Provide technical support, including failure analysis for discrepant production components, assemblies and field returns. Perform other duties as required.

Required Skills: At least 6 months (internship included) experience in mid/high volume manufacturing of complex mechanical devices Manufacturing engineering experience that includes the relevant responsibilities listed above Demonstrated mechanical and process engineering ability Demonstrated ability in failure analysis and continuous improvement. Experience in Design for Manufacturing (DFM) assessment A lab-oriented hands-on mind set; an ability to systematically and effectively break down a system or process into sub-parts to identify failure mechanisms Strong written and oral communications skills A passion for creating robust and reliable products Experienced in ISO 9001, or medical device manufacturing environment. CAD experience preferred (Solidworks, AutoCAD) Machining experience helpful A Bachelors degree in Engineering or related technical discipline