The candidate will be working in the lab, so the manager is seeking someone with a mechanical engineering background who is experienced with evaluating mechanical failures in device components, ideally within medical devices.
Responsible for creating test methods, work instructions, training and mentoring technicians who work on investigation of return and not-return products.
The QE will review result of investigations completed by others for accuracy, completeness and compliance to SOPs/WIs.
The results of investigations can be used to escalate product issues in collaboration with other Post Market functions, R&D, Design Assurance, Operations, Supplier Management, and Medical Safety.
Responsibilities:
Understanding failure modes and approving product analysis for return and non-return complaints related to mechanical medical devices performed by technicians.
Coordinating, training and supervising failure investigation activities for lab technicians.
Support integration of new products into CIS lab by creating/validating test methods and test instructions.
Creating and presenting slides for SER/CRB.
Collaborating with other Post Market (CCC/CMC) teams, R&D, Design Assurance,
Manufacturing, Supplier to help determine root cause of complaints.
Monitoring product performance and escalating any non-conformance issues with returned devices.
Creating, releasing new WI/SOPs in document control system.
Initiating and owning non-conformance investigations.
Training technicians to find root cause of complaints through sound failure analysis techniques.
Minimum Qualifications:
Bachelor’s degree in Mechanical Engineering with 2+ years of relevant experience
Bachelor's degree can be in electromechanical/electrical but the candidate needs to have hands-on experience in failure analysis.
Demonstrated problem-solving & failure analysis capabilities of mechanical systems/components
Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook
Great written/verbal communication skills and ability to collaborate with other teams
Ability to successfully multi-task and be adaptive
Preferred Qualifications:
Master’s degree in Mechanical Engineering with at least 1 year experience in similar role
Ability to understand system level functionalities, to devise and validate test methods for failure analysis of systems/components
Experience in Medical Device industry
Familiarity with Post Market requirements and systems
Familiarity complaint systems used for medical devices