Product Engineer

Responsibilities:
*Assure transfer of new combination product test methods to QC or manufacturing, by developing six sigma processes and compiling all required documentation.
*Implement projects per Combination Product Operations (CPO) and company procedures to ensure projects are completed on schedule and within established budget.
*Apply core engineering principles to develop physical test methods for medical device and combination product systems.
*Perform data analysis to support method development, qualification, validation, and transfer
*Provide expert support in the design or redesign of tools and/or equipment required for manufacturing processes.
*Provide expert support for investigations as well as new processes development required to improve manufacturing operations. Improvements may be required for a variety of reasons (i.e. quality, reliability, new product introduction, cost saving).
*Coordinate gauge and equipment development and delivery with selected contractors.
*Ensure that qualification parameters are met for product assembly and performance requirements.
*Support development of cost estimates for new processes, gauges and equipment development used in generation of capital request documentation.
*Generate procedures necessary to support department and new product equipment.
*Provide expert training to individuals in the operation and maintenance of processes, gauges and equipment introduced to the manufacturing department (i.e. production operator, mechanics, process engineers).
*Participate in and assume responsibilities of team functions as assigned (i.e. Product Improvement Teams).
*Supervise work of support staff during development and manufacture of system.
*Develops and maintains integrated timelines capturing appropriate cross functional details and deliverables which are aligned with the functional and project deliverables
*Facilitates robust horizontal communication to ensure all functions are aware of changes in deliverables and impacts to risk.
*Proactively identifies issues and/or risks and develops mitigation options to resolve or escalate efficiently

Requirements:
*Doctorate degree OR
*Master degree and 3 years of experience OR
*Bachelor degree and 5 years of experience OR
*Associate degree and 10 years of experience OR
*High school diploma / GED and 12 years of experience
*Experience performing data analysis using statistical software, (JMP, Minitab)
*Experience modeling test fixtures, reference samples on solidworks or any other CAD software
*Root cause analysis, CAPA deviation
*Equipment method and test validation experience
*Technical writing experience

Preferred:
*Experience with managing technical teams, including setting priorities and leveling resources
*Spanish language skills
*Experienced with SolidWorks (or other 3D-CAD software)
*Familiar with equipment and software IOQ
*Experience with process characterization, scale-up, technology transfer experience, pFMEAs and dFMEAs
*Experience with change controls, deviations, CAPA
*Experience with combination products and device regulatory requirements
*Understanding of the six sigma process, utilizing Minitab (or other statistical software packages) to solve statistical problems
*Work history with cGMPs, regulatory filings and compliance issues for sterile injectable products manufactured by aseptic processing
*Experience with machine controls (PLC, HMI) and vision systems