Mechanical Engineer 1

Mechanical Engineer 1

Our client, a leading Medical Device Manufacturing Company, is looking for a Mechanical Engineer 1. This is for an initial duration of 12 Months Contract in Branchburg, NJ.

Technical Skills Must Have:

• Corrective and Preventive Action (CAPA)
• Deviations
• Instron Mechanical Testing
• Minitab
• OOS Investigations
• Technical Writing
• Zwick

Job Description:

• On site 5 days a week.
• Education: Associate degree or relevant experience 2 years

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 Client 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.

Compensation: The hourly rate for this position is between $28.00-$30.00 per hour. Benefits: Sunrise offers ACA compliant medical coverage/dental insurance/vision insurance to all employees. We also offer Sick time benefits as required per State regulations.