Sr. Mold Technician

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 <5% travel for supplier/tooling support.

Required Education And Experience

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 (calipers, micrometers, optical comparator; CMM exposure a plus).

Accurate ERP/eDHR data entry (e.g., SAP, Oracle, or equivalent).

Team-oriented with experience supporting 5S and Total Productive Maintenance (TPM) initiatives.

Demonstrated communication, interpersonal, decision-making, problem-solving, and organizational skills.

Position Requirements

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 of the organization.

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 and openness to change in a dynamic global industry.

Competencies

Problem Solving/Analysis

Results Driven

Detail Orientation

Customer Focus

Technical Capacity

Communication Proficiency

GMP Documentation Discipline

Training & Mentoring

Root Cause & Problem Solving

Additional Eligibility Qualifications

None required for this position.

Work Authorization/Security Clearance

Employees must be legally authorized to work in the United States and must not be barred from working with federal contracts or government entities (e.g., listed on federal excluded-party lists).

AAP/EEO Statement

Erbe employees and applicants for employment are protected by federal laws, Presidential Executive Orders, and state and local laws designed to protect employees and job applicants from discrimination on the bases of race, religion, color, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, family medical history or genetic information, political affiliation, military service or other non-merit-based factors. These protections extend to all management practices and decisions, including recruitment and hiring practices, appraisal systems, promotions, and training and career development programs.

Other Duties

This position description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that may be required. Duties, responsibilities, and activities may change at any time with or without notice.

At-Will Employment

This position description does not constitute a contract or guarantee employment for any specified time. The company may exercise its employment-at-will rights at any time.