Hybrid Test Engineer III, Product Development (Cincinnati, OH, US, 45241) at Enable Injections

QUALIFICATIONS

Required:

• Bachelor's degree or higher in Mechanical or Biomedical Engineering from an accredited university
• A minimum of 4 years’ experience in a testing lab environment with knowledge of standard methods for mechanical testing

Preferred:

• Experience with medical device testing to meet regulatory requirements
• Experience in developing and commercializing regulated medical devices
• Experience with statistics and commercial software such as Minitab
• Experience performing root cause investigations for methods and/or products

Skills & Competencies:

• Expertise in custom test method development and validation
• Strong analytical skills and creative problem-solving skills
• Excellent verbal communication, technical writing, and presentation skills
• Ability to effectively plan and manage priorities
• Proficiency utilizing the MS Office Suite (Project, Word, Excel, PowerPoint, Visio, Outlook)
• Ability to interpret global industry standards (ex. ISO, ASTM, etc.)
• Ability to adapt behaviors and activities during times of change and handle unexpected situations with little to no guidance
• Exemplifies flexibility and resourcefulness; responds deftly to a variety of challenges and situations
• Ability to understand complexity, anticipate problems, and proactively diagnose
• Plan and carry out sequential projects
• Ability to analyze problems and troubleshoot solutions
• Apply solid cognitive ability to collecting, processing, and disseminating information
• Begin to demonstrate the ability to foster teamwork, collaboration, negotiation, and influencing others
• Engages colleagues with the Enable Values in mind
• Ability to maintain a positive attitude, show empathy for others, and always do the right thing
• Ability to understand your own emotions and their effects on your performance
• Ability to have a positive impact on others in support of company goals and a healthy work environment
• Excellent time management skills

Physical Requirements:

• Must be able to remain in a stationary position for extended periods of time
• Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc.
• Ability to move about inside the office to access file cabinets, office machinery, etc.
• Ability to operate lab instrumentation and equipment
• Ability to lift and move 20 lbs.
• Position requires being physically present on the premises during regular company hours or as approved by management

RESPONSIBILITIES:

• Work closely with product development, manufacturing engineering, and quality engineering to ensure test methods are adequately verifying requirements
• Write detailed test protocols and reports to support regulatory submissions
• Lead technical presentations to share results and findings with other engineers
• Conduct root cause analysis on test failures and manufacturing defects
• Analyze test results utilizing statistical methods
• Collaborate with test technicians to run feasibility and verification tests
• Participate in design reviews and utilize experience to mitigate design and process risks
• Identify areas of inefficiency and implement organization initiatives such as Lean or 5S
• Adhere to company procedures, industry regulations and customer requirements
• Identify lab needs and manage procurement for equipment and supplies