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.