Job Description:
The individual chosen for this position will primarily be responsible for closing out process validations of a pilot manufacturing line for next-generation subcutaneous glucose sensors. Day to day responsibilities include execution of validation test plans and generation of validation test reports. In addition, this individual will aid in the setup of a high volume manufacturing line for the same product (characterization, IQ/OQ/PQ).
Position Responsibilities:
- Coordinate sample builds and maintain traceability documentation
- Prepare process validation protocols (IQ/OQ/PQ) and generate accompanying test plans/reports
- Route and track all protocol documents for proper approvals
- Characterize new process equipment
- Document experiments and results in engineering reports
- Create and present summary presentations to management
- Collaborate and coordinate with outside vendors
- Provide technical support to engineering, and provide line support as required
- Obtain test data and provide statistical analysis to generate status reports for engineering
- Initiate revision of controlled drawings of components and assemblies as needed
- Create or revise assembly procedure documents
- Provide process expertise and training as necessary
- Identify safety issues in the immediate work environment and other work areas and recommend solutions for improvement
Basic Qualifications:
- BS in Biomedical/Mechanical/Chemical Engineering
- Experience in working in a clean room environment or wet lab environment
- Experience in analysing large data sets and performing relevant statistical analysis
- Proficient in writing technical reports, procedures, and/or reference documents
- Ability to multitask and meet deadlines
- Must have excellent verbal and written communication skills
- Must have experience in developing Design of Experiments (DOEs)
- Must have strong attention to detail
- Proficient in MiniTab statistical analysis software
Education Required:
- Minimum BS in Biomedical/Mechanical/Chemical Engineering
Desired/Preferred Qualifications:
- Medical device or healthcare industry experience
- Proficient in MiniTab statistical analysis software