Sr. Mold Technician

Erbe USA Incorporated
Tempe, AZ
Job Details

Description

Essential Responsibilities

This Position Will Be Responsible To

Maintain and control process conditions on assigned molding machines, robots, and related equipment to meet quality and throughput targets.

Follow released work instructions/SOPs; monitor materials, molds, equipment, cycle times, and part quality.

Resolve issues related to tooling alignment, part handling, runner containment, part placement, sensors, and process parameters through proper adjustment of programs, speeds, timers, and hardware.

Perform preventive maintenance (PM) on machines, molds, and auxiliary equipment to ensure readiness and reliability.

Support the molding team with departmental tasks as required to meet the production schedule.

Execute and document work per operating procedures, work instructions, and DHR/eDHR requirements; ensure records are complete, accurate, and contemporaneous (ALCOA+).

Adhere to 21 CFR 820, ISO 13485, cGMP, and internal document control (use of latest released revisions).

Identify, contain, and document nonconforming product; support MRB decisions and implement corrective actions as required.

Participate in change control and process validation activities (IQ/OQ/PQ), including executing validation runs and recording molding parameters and results.

Follow lot traceability and label control requirements for materials, components, and finished goods.

Support internal and external audits and provide objective evidence of compliance.

Establish and sustain decoupled (II/III) processes using cavity pressure/velocity principles; develop validated process windows (nominal, min, max) and lock them in setup documentation.

Verify material conditioning (e.g., resin drying time/temp, moisture %) and machine/mold readiness (barrel residence time, check-ring repeatability, clamp tonnage, venting).

Apply SPC and capability metrics (Cp/Cpk, Pp/Ppk) to CTQ features; escalate adverse trends and perform DOE/root-cause analysis (5-Why, fishbone).

Maintain and back up robot programs and molding setup sheets; ensure revision control.

Perform and document first-article/first-piece approvals and in-process inspections per sampling plans.

Operate and troubleshoot auxiliary equipment (dryers, blenders, TCU/chillers, hot runners, conveyors, vision systems) and automation (EOAT) with documented PMs.

Comply with Lockout/Tagout (LOTO), machine guarding, crane/hoist, and forklift procedures; wear required PPE (heat-resistant gloves, safety glasses, cut-resistant sleeves, etc.).

Supervisory Responsibility

This position is an individual contributor and has no direct supervisory responsibility.

Work Environment

Work is performed in both office and manufacturing environments, with routine use of computers and standard office tools. The role regularly interacts with molding presses, auxiliary equipment, robots, and automation on the manufacturing floor. This role requires the usage of controlled environment gowns.

Physical Demands

While performing the duties of this job, the employee is regularly required to speak and hear; frequently required to stand, walk, stoop, use hands to finger/handle/feel, and reach with hands and arms. The employee frequently lifts and/or carries up to 50 lb. with lift assist (hoists/carts provided). For more information, refer to the Position Analysis/Physical Activities Checklist on file in Human Resources.

Position Type and Expected Hours of Work

Full-time, Monday-Thursday, 5:30a.m. - 4:00 p.m.

Occasional off-shift, overtime, and weekend coverage may be required based on production and validation needs. (Shift assignments may change with business demand; shift differentials apply per policy.)

Travel

This position requires
Posted 2025-10-02

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