QA Mechanical Engineer

Role: QA Mechanical Engineer

Location: Valencia, CA 91355

Duration: 12 Months (Possible extension/Hire)

Job Description:

• 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
• Experience with using SAP and Power BI