Position : Product Test Engineer/Mechanical Test Engineer 1
Location : Branchburg, NJ
Duration : 12 Months
1 st Shift
Total Hours/week : 40.00
Client : Medical Devices Company
Job Category : Engineering
Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT
On site 5 days a week
Pay rate: $30/hr
JOB DESCRIPTION
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
· Works and communicates openly, collaboratively, and respectfully with colleagues and staff
· Communicates with clients under the 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 recommended
· Attention to detail with the ability to multi-task in a fast-paced environment and manage changing priorities with the capacity to effectively communicate across the organization.