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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
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