Manufacturing Engineer-Medical Device

Tri Alpha Energy   •  

Foothill Ranch, CA

Industry: Energy & Utilities

  •  

5 - 7 years

Posted 122 days ago

Description

TAE Technologies is leveraging proprietary science and engineering to tackle the world’s biggest challenges. A recently formed sister company of TAE is looking into cancer-fighting applications using a particle accelerator similar to those that have been developed for the fusion application.We are looking for a Medical Device Manufacturing Engineer who is responsible for providing manufacturing and quality assurance and compliance and testing support to R&D.

Responsibilities:

  • Leads design transfer activities to support transition from R&D to manufacturing.
  • Develops equipment and process validation requirements (Process FMEA, IQ, OQ, PQ).
  • Provides engineering support to manufacturing.
  • Determines process improvements to improve product quality.
  • Generates internal quality documentation such as quality plans, SOPs and inspection procedures. Ensure QA, FDA and ISO compliance in all areas of responsibilities.
  • Provides all planning necessary to ensure effective product acceptance based on Device Master Record.
  • Reviews production schedules and support product acceptance activities.
  • Assists in monitoring field quality issues and analyzing field returns.
  • Performs data analysis and investigations. Tracks quality trends and initiates action items to resolve issues.
  • Participates in internal and external quality audits.
  • Uses statistical tools to analyze data, make acceptance decisions, and improve process capability.
  • Design of tooling, fixtures, and packaging to aid in the supplier build and assembly processes and ensure safe transport.
  • Design tests to verify and validate design.
  • Provide technical review and assessment when qualifying new suppliers.

 Job Requirements: 

  • B.S. degree in an Engineering discipline.
  • 5+ years of related experience in medical device industry
  • Detailed knowledge of ISO 13485 and the FDA 21 CFR, Part 820, Quality System Regulation.
  • Certified ISO 13485 
  • Knowledge of six sigma methodologies preferred.
  • Experience in managing/coordinating engineering activities.
  • Experience with ERP systems.
  • Excellent organizational, problem-solving, and analytical skills.
  • Good interpersonal skills.
  • Ability to identify problems, and develop and implement actions to resolve them.