Experienced Plastic Engineer

Senior Supplier Engineer

Function: Supply Chain Engineering

Sub-Function: Process Engineering

Category: Senior Engineer, Process Engineering (ST6)

Location: Danvers, Massachusetts, United States

Position Summar

yWe are seeking an experienced Senior Supplier Engineer to serve as the primary technical interface with suppliers and drive supplier-related engineering initiatives across the product lifecycle. This role focuses on electronic assemblies, electrical components, printed circuit board assemblies (PCBAs), and console/box-build manufacturing

.The successful candidate will lead supplier development activities, support new product introductions, qualify secondary sources, drive process improvements, and establish robust quality systems with key manufacturing partners. This position plays a critical role in ensuring supplier performance, product quality, manufacturing scalability, and supply continuity within a regulated medical device environment

.Principal Duties and Responsibilitie

• sAct as the primary technical point of contact with suppliers providing electronic assemblies, electrical components, PCBAs, and console/box-build products
• .Lead recurring technical meetings with suppliers to manage engineering projects, including process validations, failure investigations, component obsolescence mitigation, and manufacturing capacity expansion
• .Partner with supplier engineering teams to analyze manufacturing processes and develop data-driven yield improvement initiatives
• .Evaluate manufacturing constraints and develop capacity expansion plans aligned with forecasted demand
• .Conduct risk assessments using FMEA methodologies and develop process validation plans, including MVP, IQ, OQ, and PQ activities
• .Collaborate with internal design teams to evaluate product lifecycle changes and develop qualification and verification test plans
• .Support incoming quality and inspection teams by investigating defects, managing non-conformances, and driving corrective actions
• .Utilize project management tools to establish milestones, track deliverables, and communicate project status
• .Support product development programs by serving as the supplier engineering liaison for technical deliverables and supplier interactions
• .Influence product design by representing supplier capabilities and advocating for Design for Manufacturability (DFM) and Design for Testability (DFT) improvements
• .Participate in supplier selection activities and lead qualification efforts for second-source suppliers
• .Drive continuous improvement initiatives focused on quality, cost, delivery, and manufacturing efficiency

.Required Qualification

• sBachelor's degree in Electrical Engineering, Manufacturing Engineering, or a related technical discipline. Master's degree preferred
• .Minimum of 5 years of relevant engineering experience, preferably within organizations that design, manufacture, or assemble
• :Electronic component
• sPrinted circuit board assemblies (PCBAs
• )Console/box-build system
• sInjection-molded or plastic component
• sDemonstrated experience with
• :PCB manufacturing processe
• sSurface Mount Technology (SMT
• )Electronic component design and assembl
• yBatteries, cables, connectors, displays, and console/box-build manufacturin
• gExperience supporting the design, manufacturing, or process improvement of injection-molded and/or extruded plastic components
• .Knowledge of direct material management processes, including
• :Incoming inspection plannin
• gMaterial Review Board (MRB) participatio
• nNon-conformance investigations and dispositio
• nERP system management (SAP experience preferred
• )Experience developing and executing process validation activities, including IQ/OQ/PQ protocols and reports
• .Experience with Measurement System Analysis (MSA) and Gauge R&R studies preferred
• .Strong root cause analysis and problem-solving skills, including validation of failure mechanisms
• .Knowledge of Statistical Process Control (SPC), including
• :Run chart
• sIM-R chart
• sControl limit
• sProcess capability and control methodologie
• sLean Six Sigma Green Belt or Black Belt certification preferred
• .Basic metrology experience using
• :Caliper
• sGauge pin
• sVision system
• sOptical comparator
• sWorking knowledge of project management principles, including
• :Schedule managemen
• tStakeholder managemen
• tConflict resolutio
• nCritical path identificatio
• nProficiency with Microsoft Office applications
• .Knowledge of FDA 21 CFR Part 820 and ISO 13485 requirements
• .SAP experience preferred
• .Ability and willingness to travel up to 20%, both domestically and internationally

.Preferred Competencie

• sAgile Decision Makin
• gCoaching and Mentorin
• gCorrective and Preventive Action (CAPA
• )Critical Thinkin
• gEmerging Technologie
• sIssue Escalation Managemen
• tLean Supply Chain Managemen
• tProblem Solvin
• gProcess Contro
• lProcess Engineerin
• gProduct Cost Optimizatio
• nProduct Improvement Initiative
• sSTEM Applicatio
• nSituational Awarenes
• sTechnical Researc
• hTechnology Adoption and Innovatio
• nValidation Testin
• gSupplier/Vendor Selectio

nRegulatory and Industry Knowledg

• eMedical device manufacturing environment
• sSupplier quality management system
• sRisk management methodologie
• sProduct lifecycle managemen
• tProcess validation and qualificatio
• nDesign transfer and manufacturing scale-u
• pRegulatory compliance requirements for medical device