This position is for a Manufacturing Engineer This role will support a lead manufacturing engineer during development and validation of a new production lines for a new medical device Responsibilities include, but are not limited to:
• Support development and validation for new production processes.
• Manage product BOM configurations in PLM system.
• Develop and characterize the manufacturing process window and secure process capability across all variation in production materials and processes.
• Develop and execute plans, including statistical analysis, to evaluate process repeatability through equipment qualification and process validation (IQ/OQ/PQ).
• Define and generate all required documentation in support of manufacturing protocols, reports, changes, and manufacturing instructions These include Engineering protocols, reports, process risk documents (PFMEA), manufacturing instructions, change orders and statistical analysis.
• Provide engineering support to manufacturing operations and address quality issues arising on the production floor.

Requirement:

Minimum Requirements
• Bachelor's Degree in a technical discipline
• Minimum 4 years of experience required.

Nice to Have
• Master's Degree in a technical discipline
• Medical Device and/or Manufacturing Experience
• Experience with materials joining process, such as laser welding, ultrasonic welding, or resistance welding.
• Laser marking experience.
• Experience developing vision inspection/verification systems.
• Experience in an electronics manufacturing environment

Top 3 technical skills that you are required for the role:
1 Process Validation
2 PLM Experience
3 Gauge R&R

Years' Experience Required: 4 years minimum

Nice To Have
Ability to use statistical techniques to analyze data capable of developing/reviewing/approving test plans and reports experience in Medical devices manufacturing Interpersonal Skills investigate and collaborate in the investigation of atypical events to support product disposition PFMEA
agile plm
Basic knowledge of Laser Welding and Leak Tester machines.
Gauge R&R analysis
Medical Manufacturing Engineer
medical manufacturing experience
Ultrasonic Welding
vision inspection system programming

Benefits:

Benefits include:
-MEC/ACP Medical
-Voluntary Dental, Vision, Life, Supplemental Income
-401k (must meet requirements)
-sick leave as required by state/county
ATR International Inc will not sponsor applicants for the following work visas H1B and STEM OPT I-983 form.