78 applicants
Pro5.ai (formerly Mangtas) · 5 days ago
Process Engineer
Irvine, CA
Contract
Onsite
Mid Level
2+ years exp
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Hiring Manager
Wouter Delbaere
Insider Connection @Pro5.ai (formerly Mangtas)
Responsibilities
Perform product trainings to repair center technicians & staff.
Assemble and disassemble small highly delicate parts of the medical device assuring the unit meets the established specifications.
Ensure that internal activities and external partnerships adhere to applicable regulations and quality standards, including FDA QSR and ISO 9001/ISO 13485.
Apply quality and regulatory standards to medical equipment and process qualification.
Interpret internal requirements and write SOP and work instruction.
Diagnose problems, replace or repair parts, test and make adjustments.
Provide CAPA, complaints, audit and overall QMS support.
Perform final quality inspection on the completed repair to ensure the product is up to the manufacturer's original specifications before passing the scope along to the final quality control station.
Troubleshoot potential problems not originally discovered during the initial inspection.
Operate required equipment in a safe manner following established safety rules, maintain a neat and clean work area, follow established tool and instrument control procedures, and report any unsafe acts or conditions to immediate supervisor.
Adhere to all safety policies and procedures.
Comply with all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations and standards.
Qualification
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Required
Electronic and/or Mechanical Certification or degree. Plus 2-5 years’ experience working in a medical repair or similar environment preferably in the endoscopy field.
Electronic and mechanical skills required.
Solder skills and experience required.
Must follow instructions and apply to real situations in a very quick manner.
Reach monthly targets on a consistent basis.
Ability to meet and/or exceed deadlines.
Able to professionally communicate with internal and external customers.
Able to investigate and resolve discrepancies.
Ability to research and analyze various different types of information.
Ability to prioritize work.
Ability to read, analyze, and interpret essential job-related documents.
Ability to present and speak effectively and professionally to employees of the organization.
Ability to calculate and match figures and amounts.
Company
Pro5.ai (formerly Mangtas)
Pro5 is an AI platform, specialized in finding and hiring the top 5% of remote professionals from cost-effective markets for roles like software developers, sales reps, and customer service experts.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase
