Position Details

Salary $94K – $151K USD / year

Type Not Specified

Experience senior

Exp. Years 3+ years

Education Bachelor's degree in plastic engineering, manufacturing engineering or related field

Category Engineering (Non-Software)

About this role

Senior Supplier Engineer with focus on external manufacturing for cardiovascular solutions. Leads supplier initiatives, validates processes, and ensures quality at the source for injection molded and extrusion plastics components, with an emphasis on DFx and supplier integration.

Key Responsibilities

Act as primary technical contact with suppliers for injection molded or extrusion components and finished goods
Lead supplier meetings to manage engineering projects and validations
Develop yield improvement plans with supplier teams
Perform process constraints analysis and capacity planning
Assess risk via FMEAs and manage IQ/OQ/PQ at suppliers

Technical Overview

Technical scope includes DFx, FMEA, IQ/OQ/PQ, process validations, MRB, SAP/ERP, and metrology. Environment spans medical device manufacturing with ISO 13485 and FDA regulations; travel up to 20%.

Ideal Candidate

The ideal candidate is a senior supplier engineer with 3+ years in a medical device manufacturing environment, proficient in injection molded and extrusion plastics, and experienced with FMEA, IQ/OQ/PQ and DFx. They should have SAP/ERP experience, ISO 13485 familiarity, and Lean Six Sigma Green Belt certification, with the ability to travel up to 20%.

Must-Have Skills

Bachelor's degree in plastic engineeringmanufacturing engineering or related field3+ years experience in a manufacturing environmentExperience with injection molded and/or extruded plastics componentsExperience with process validation (IQ/OQ/PQ)FMEA / risk assessmentRoot cause investigationSAP / ERP experienceKnowledge of FDA 21CFR820/821 and ISO 13485Willingness to travel up to 20%

Nice-to-Have Skills

Lean Six Sigma Green Belt or Black BeltMRB investigationsQuality at the Source programGage R&R studies

Tools & Platforms

SAPMicrosoft Office Suite

Required Skills

Bachelor's degree in plastic engineeringmanufacturing engineering or related field3+ years experience in manufacturinginjection molded and/or extruded plastics componentsIQ/OQ/PQFMEAMRB investigationsSAPERPISO 13485FDA 21CFR820/821MS Office SuiteLean Six Sigma Green Beltcalibration/metrology tools

Hard Skills

Injection moldingextrusionQuality at the SourceFMEAFMEAsIQ/OQ/PQMVPDFx (Design for Manufacturing and Test)Second sourceSAPERPMRB investigationsRoot cause analysisStatistical Process ControlSPCLean Six Sigma Green Beltcalipersgauge pinsvision systemoptical comparatorMS Office SuiteFDA 21CFR820/821ISO 13485Travel up to 20%

Soft Skills

communicationproblem solvingcollaborationstakeholder managementteamwork

Certifications

Preferred

Lean Six Sigma Green BeltLean Six Sigma Black Belt

Industry & Role

Industry Healthcare & Medical

Job Function Lead supplier engineering initiatives with external manufacturers to ensure compliant, quality, scalable production of injection molded plastic components for Cardiovascular therapies.

Role Subtype Engineering (Non-Software)

Tech Domains SAP, Microsoft Office Suite

Keywords for Your Resume

Senior Supplier Engineersupplier engineerinjection moldedextrusion componentsfinished goodsFMEAFMEAsIQ/OQ/PQMVPDFxDesign for Manufacturing and TestMRB investigationssecond sourceSAPERPISO 13485FDA 21CFR820/821Lean Six Sigma Green Beltcalipersgauge pinsvision systemoptical comparatorMS Office Suitetravel up to 20%

Deal Breakers

Bachelor's degree not in plastics/manufacturing, No experience with injection molded plastics, No experience with FMEA or IQ/OQ/PQ, Unwilling to travel up to 20%

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