What are the responsibilities and job description for the Mechanical Engineer position at REQ Solutions?
Job Title: Mechanical Engineer
Duration: 12 Months (Possible extension)
Location: Valencia, CA 91355
Onsite Role
Responsibilities:
- 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.
- Understanding failure modes and approving product analysis for return and non-return complaints related to electro-mechanical 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 investigation
- Training technicians to find root cause of complaints through sound failure analysis techniques
Education/Experience:
- 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
Preferred:
- Masters 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 PowerBI
Salary : $45 - $52