Sr. Mold Technician

Overview

Sr. Mold Technician role at Erbe USA Incorporated. This position is an individual contributor with no direct supervisory responsibilities.

• 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 and lock them in setup documentation.
• Verify material conditioning and machine/mold readiness (e.g., resin drying time/temp, moisture %, 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.
• 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 with documented PMs.
• Comply with Lockout/Tagout (LOTO), machine guarding, crane/hoist, and forklift procedures; wear required PPE.

• High school diploma required; AS in Plastics/Manufacturing Technology preferred.
• 7+ years hands-on injection molding, including scientific molding/decoupled processing and robot/EOAT setup.
• Experience supporting IQ/OQ/PQ and working within QSR/ISO 13485.
• Proficiency with RJG or equivalent cavity-pressure methodology (Master Molder I/II preferred).
• Working knowledge of hot runner systems, mold maintenance (ejector alignment, venting, polish), and resin handling (moisture control).
• Familiarity with SPC, gage R&R, and basic metrology; CMM exposure a plus.
• Accurate ERP/eDHR data entry (e.g., SAP, Oracle, or equivalent).
• Team-oriented with experience supporting 5S and TPM initiatives.
• Demonstrated communication, interpersonal, decision-making, problem-solving, and organizational skills.
• Medical device or other regulated industry experience preferred.
• Excellent verbal and written communication; strong facilitation and interpersonal skills; ability to communicate complex information at all levels.
• Proficiency with MS Office and production systems; detail-oriented; able to produce high-quality work in a high-volume environment.
• Ability to handle confidential information appropriately and professionally; flexibility to adapt in a dynamic global industry.

Work is performed in both office and manufacturing environments; routine computer use; regular interaction with molding presses, auxiliary equipment, robots, and automation. Use of controlled environment gowns may be required.

Regularly required to speak and hear; may stand, walk, stoop, use hands, reach; may lift/carry up to 50 lb. with assistance.

Full-time, Monday-Thursday, 5:30 a.m. – 4:00 p.m. Occasional off-shift, overtime, and weekend coverage may be required. Travel up to 5% for supplier/tooling support.

Estimated travel, education, and experience requirements reflect the needs of this role; refer to job posting for specific details.

Erbe employees and applicants are protected by federal, state, and local laws against discrimination based on race, religion, color, sex, national origin, age, disability, and other protected statuses.

Employees must be legally authorized to work in the United States and not barred from federal contracts or government entities.