Product Test Engineer - Req Instron Mechanical Testing & Medical Device Industry Exp
Quality AssuranceFull-time
Position Summary
- The primary role of the Combination Product Test Engineer is the timely and accurate execution of testing as scoped within individual projects and per client requirements.
- This includes but is not limited to; sample receipt, prep, storage and shipping, as well as protocol and report generation, data review and summary.
- This role utilizes standard and custom laboratory equipment.
Essential Duties and Responsibilities
- Conducts timely sample intake, including receipt, proper identification, storage and return shipments as needed.
- Conducts testing as assigned utilizing appropriate test methods, protocols specifications and equipment (includes product and/or equipment testing), including adhering to test schedules (e.g. stability pulls, aging pulls).
- Conducts data analysis as per protocol or specifications utilizing variety of data analysis tools (e.g. excel, JMP, MiniTab).
- Communicate challenges, scheduling or testing conflicts and other issues to management in timely manner.
- Maintains inventory of lab supplies, including but not limited to; general supplies (e.g. PPE, wipes, cleaners…) and chemicals use for routine testing and/or cleaning.
- Conducts routine sample disposition (e.g. return to client, disposal), including coordination of hazardous waste disposal.
- Responsible to maintain the lab and storage areas in a clean an organized manner. Includes routine lab cleaning and housekeeping.
- Adheres to ZebraSci Quality Systems, including but not limited to; timely identification, and notification of potential Quality Events (e.g. OOS, Deviations, CAPA…) and the subsequent forward processing and investigation of such events.
- Follows established Standard Operating Procedures, makes recommendations for edits, enhancements, and/or new procedures.
- Reviews and may draft equipment or other lab documents (e.g. SLP, LWIs) under supervision from lab management.
- Reviews test results, including data analysis and draft reports.
- Interacts with clients to provide updates and technical overviews as needed under supervision from lab management.
- Reviews and may author test methods/protocols/reports under supervision from lab management.
Education, Experience and Skills
- Associates degree with 0-2 years’ experience.
- A combination of education and experience in laboratory services, medical device, IVD and/or pharmaceutical industry, preferably in a contract testing and/or laboratory environment will be considered.
- Knowledge of GLP, cGMPs, ISO and ASTM methodologies beneficial. Technical written/oral communication skills with working knowledge of Excel and other data analysis tools required.
- Attention to detail with the ability to multi-task in a fast-paced environment and manage changing priorities.