Engr 1, Mechanical

On site 5 days a week . Education As Degree or relevent 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

1. Conducts timely sample intake, including receipt, proper identification, storage and return shipments as needed

2. 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).

3. Conducts data analysis as per protocol or specifications utilizing variety of data analysis tools (e.G. Excel, JMP, MiniTab)

4. Communicate challenges, scheduling or testing conflicts and other issues to management in timely manner

5. 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

6. Conducts routine sample disposition (e.G. Return to client, disposal), including coordination of hazardous waste disposal

7. Responsible to maintain the lab and storage areas in a clean an organized manner. Includes routine lab cleaning and housekeeping

8. Adheres to 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

9. Follows established Standard Operating Procedures, makes recommendations for edits, enhancements, and/or new procedures

10. Reviews and may draft equipment or other lab documents (e.G. SLP, LWIs) under supervision from lab management.

11. Reviews test results, including data analysis and draft reports

12. Interacts with clients to provide updates and technical overviews as needed under supervision from lab management

13. Reviews and may author test methods/protocols/reports under supervision from lab management

14. Works and communicates openly, collaboratively, and respectfully with colleagues and staff

15. 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.
Shift: ['Corrective and Preventive Action (CAPA)', 'Deviations', 'Instron Mechanical Testing', 'Minitab', 'OOS Investigations', 'Technical Writing', 'Zwick']