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.
- 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.
- 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.