Position Details

Salary $70K – $110K USD / year

Type Not Specified

Experience lead

Exp. Years 4-6+ years

Education Bachelor's degree (BS) in Engineering, or equivalent, from an accredited four (4) year college or university preferred

Category Engineering (Non-Software)

About this role

Lead Principal Molding Engineer focused on injection molding operations, project management, and molding validations. Drive cost reduction, process control, and regulatory compliance within a regulated manufacturing environment.

Key Responsibilities

Lead CER/CER projects for molding operations
Define scope, budgets, and timelines for CER projects
Review molding designs for safety, quality, and efficiency
Develop operating procedures for molding equipment
Write ECRs and validation protocols

Technical Overview

Expertise in injection molding, molding process design and validation, with strong CAD/CMMS capabilities. Regulatory focus includes GMP and ISO 13485; uses FMEA, DOE, CAPA, and ECRs to improve quality and reliability.

Ideal Candidate

The ideal candidate is an injection molding engineer with 4-6+ years of molding experience, familiar with RJG Master Molder certification, molding process design/validation, and capable of leading CAPA/validation initiatives in a regulated environment.

Must-Have Skills

None listed

Nice-to-Have Skills

Molding process design/validationMaster Molder / RJG CertificationCAD/CMMS preferred

Tools & Platforms

CADCMMSFMEAProcess MapsDOEECRsECRValidation ProtocolsValidation

Required Skills

Bachelor's degree in Engineering; 4-6+ years injection molding experience; molding process design/validation; Master Molder / RJG Certification; CAD/CMMS; FMEA; Process Mapping; DOE; GMP; ISO 13485; ECRs; CAPA; as-built drawings

Hard Skills

Injection MoldingMolding Process DesignMaster MolderRJG CertificationCADComputer Aided DraftingCMMSComputerized Maintenance Management SystemFMEAFailure Modes and Effects AnalysisProcess MapsC&E MatrixCause and Effect MatrixDesign of ExperimentsDOEValidation ProtocolsValidationGMPISO 13485Engineering Change RequestsECRsMolding Validations

Soft Skills

LeadershipMentoringCommunicationTeamworkProblem solvingProject ManagementAttention to detailDecision makingAnalytical thinking

Certifications

Preferred

Master Molder (RJG) Certification

Industry & Role

Industry Manufacturing

Job Function Lead molding engineering programs and capital projects for injection molding operations in a regulated manufacturing setting

Role Subtype Lead Molding Engineer

Tech Domains CAD, CMMS, GMP, ISO 13485, FMEA, Process Mapping

Keywords for Your Resume

principal molding engineermolding engineerinjection moldingcapital expenditurecerengineering change requestsecrmolding process designmaster molderrjg certificationvalidation protocolsvalidationgmpiso 13485cadcmmsfmeadesign of experimentsprocess mapsc&e matrixcause and effect matrix

Deal Breakers

Lack of injection molding experience, No Bachelor's in Engineering, No CMMS/CAD experience, Not able to work in Deland, FL

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