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 manufacturing process improvement initiatives and capital equipment projects in a regulated environment. Oversee design reviews, safety and regulatory compliance, and documentation for capital projects and process changes.

Key Responsibilities

Hands on process improvements with manufacturing instruments to solve technical problems
Project Management of Capital Expenditure Request (CER) projects including scope, timelines, and budgets
Review mechanical design for safety, quality, efficiency, and reliability
Ensure new equipment meets safety and environmental requirements
Write and maintain technical documentation, drawings, and validations

Technical Overview

Focus on process improvement, CAPA, and validation in a GMP/ISO 13485 environment. Utilizes CAD, CMMS, FMEA, DOE, and process mapping to drive improvements and risk reduction.

Ideal Candidate

The ideal candidate is a mid-to-senior level manufacturing engineer with 4+ years of experience in regulated manufacturing environments, strong CAPA, CAD/CMMS proficiency, and proven ability to manage capital expenditure projects and validations.

Must-Have Skills

None listed

Nice-to-Have Skills

Bachelor's degree in Engineering preferred4-6+ years experience preferredCMMS preferredCAD proficiency preferredGMP/ISO 13485 experience preferred

Tools & Platforms

CADComputer Aided DraftingCMMSComputerized Maintenance Management SystemEngineering Change RequestsECRsFMEAProcess MapsC&E MatrixCause and Effect MatrixValidation ProtocolsValidation

Required Skills

Bachelor's degree in Engineering; injection molding-related capabilities? (see Job 2); 4-6+ years; CAD; CMMS; FMEA; DOE; Process Maps; CAPA; ECRs; GMP; ISO 13485; Validation; ECRs; CAPA; as-built drawings

Hard Skills

CADComputer Aided DraftingCMMSComputerized Maintenance Management SystemFMEAFailure Modes and Effects AnalysisProcess MapsCause and Effect MatrixDesign of ExperimentsDOEValidation ProtocolsValidationGMPGood Manufacturing PracticeISO 13485Engineering Change RequestsECRsas-built assembly drawings

Soft Skills

LeadershipMentoringCommunicationTeamworkProblem solvingProject ManagementAttention to detailDecision makingAnalytical thinking

Industry & Role

Industry Manufacturing

Job Function Lead manufacturing process improvement initiatives and capital equipment projects in a regulated environment

Role Subtype Lead Manufacturing Engineer

Keywords for Your Resume

Principal Manufacturing EngineerCapital Expenditure RequestCEREngineering Change RequestsECRValidation ProtocolsValidationProcess MapsCause and Effect MatrixFMEADesign of ExperimentsDOECADComputer Aided DraftingCMMSComputerized Maintenance Management SystemGMPGood Manufacturing PracticeISO 13485CAPACorrective and Preventive Actionas-built assembly drawings

Deal Breakers

Bachelor's degree in Engineering not met, Less than 4 years related experience, Unable to work in Deland, FL, Lack of CAD/CMMS experience

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