Responsibilities: The Process Engineer is responsible for meeting production standards, ensuring product quality and process flow, and supporting the implementation of new projects.
Development of manufacturing processes for medical devices.
Molding, extrusion, bonding, curing, electrical testing, and other complex assembly methods of devices.
Packaging is a plus.
The position is responsible for creating standard production processes that meet the expected safety, quality, and production volume standards for new products.
The candidate must have the skills to work directly with external customers to develop their devices within the proposed timelines and manage relationships with external suppliers.
High levels of critical thinking and problem-solving through root cause analysis methods.
Think critically to improve production efficiency.
Provides support to CAPA, non-conformances (NCRs) as needed.
Conducts risk analysis through pFMEA and establishes critical processes.
Can draft or review product documentation, including manufacturing work instructions, drawings, proposals, and technical reports.
Creation of the master validation plan and execution of the required validations (IQ, OQ, PQ).
Frequent internal collaboration with ATL's engineering, quality, production, and sales groups to ensure the successful launch of new products and line transfer activities.
As a senior-level process engineer, provide guidance and support to junior engineering staff.
Requirements: Exposure to process development and validation activities such as PFMEAs, validation plans, IQ/OQ/PQ, PPAP, scientific molding, design of experiments (DOE), etc.
Bachelor's degree in Engineering (MBA desirable).
Minimum of 6 to 10 years of experience or a combination of education and experience equivalent to 6 years.
Experience in designing components for plastic injection molding, metal forming/stamping, and electro-mechanical devices.
SolidWorks certification is preferred.
Technical writing skills are preferred.
Exposure to manufacturing processes such as injection molding, vertical molding, extrusion, metal forming/stamping, surface-mount technology (SMT), electro-mechanical devices, etc.
Manufacturing experience is a must.
English B2+ or C1.
Job Posted by ApplicantPro