Job Description

• Test Method development/validation experience, Equipment qualification and implementation
• Experience with regulated industry, preferred
• Experience with data analysis, preferred
• BS or Masters Degree with a minimum of 3-4 years of experience

• 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.
• Excellent communication (written and verbal) and organizational skills
• Develops and maintains integrated timelines capturing appropriate cross functional details and deliverables which are aligned with the functional and project deliverables
• Networks with manufacturing, quality and regulatory organizations both internal and external to client
• 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
• Integrates partner/vendor timelines with timelines as appropriate

• Doctorate Degree OR
• Master's Degree and 3 years of Engineering experience OR
• Bachelor's Degree and 5 years of Engineering experience OR
• Associate's degree and 10 years of Engineering experience OR
• High school diploma/GED and 12 years of Engineering experience.

• M.S. or Ph. D. in Mechanical, Aerospace, Mechatronics, Chemical or Biomedical engineering
• Excellent written and verbal communication skills together with demonstrated ability to work in a highly matrixed team environment
• Experience with managing technical teams, including setting priorities and leveling resources
• Technical writing experience
• Spanish language skills preferred
• 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

• No formal engineering training
• Job Jumping - multiple job changes in a year

• Phone
• In Person/webex panel