Supplier Process Engineer

Job Title

Job Overview:

Requirement/Must Have:

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, Electrical Engineering, or equivalent technical discipline.
• Minimum 2–5 years of experience in Supplier Engineering, Manufacturing Engineering, Quality Engineering, Supplier Quality, or related field.
• Experience supporting high-volume manufacturing environments, preferably in medical devices or regulated industries.
• Hands-on experience with manufacturing processes such as machining, MIM, injection molding, stamping, extrusion, or assembly processes preferred.
• Experience supporting New Product Introduction (NPI) and production scaling preferred.

Responsibilities:

• Serve as the primary technical interface between plant manufacturing teams and suppliers for quality issues, line disruptions, yield loss, delivery concerns, and capacity constraints.
• Lead supplier issue resolution from containment through root cause investigation and corrective/preventive action implementation.
• Support manufacturing operations by investigating and resolving supplier-related deviations, variances, nonconformances, and first article issues.
• Monitor supplier performance across quality, delivery, responsiveness, and manufacturing stability, driving improvement where gaps exist.
• Support uninterrupted production by proactively managing supplier risks and escalating critical issues appropriately.
• Work directly with suppliers to improve manufacturing processes, process capability, inspection methods, and process controls.
• Drive sustainable corrective actions using structured problem-solving methodologies and data-driven analysis.
• Lead investigations into recurring defects, quality escapes, process variation, and manufacturing inefficiencies impacting production.
• Partner with suppliers to improve yield, reduce variability, and strengthen manufacturing robustness.
• Build and execute supplier development plans using Lean Manufacturing, Six Sigma, SPC, and continuous improvement principles.
• Own and execute supplier qualification and validation activities, including supplier pFMEA, IQ/OQ/PQ and process validations, first article inspections and inspection reports, and gage R&R and process capability analysis (Cp/Cpk).
• Support execution and closure of Variance Requests (VRs), Supplier Change Requests (SCRs), and supplier-driven manufacturing changes.
• Approve and manage supplier process changes including new equipment, process transfers, facility moves, tooling changes, and production line validations.
• Support implementation of ECO changes impacting suppliers, ensuring validation and risk mitigation prior to production release.
• Assess supplier readiness and manufacturing capability to support sustaining production and NPI ramp activities.
• Identify and proactively manage supplier-related risks including quality, capacity, continuity, and manufacturing constraints.
• Convert recurring supplier issues into structured improvement initiatives to eliminate root causes.
• Drive continuous improvement projects focused on quality, operational efficiency, manufacturing consistency, and supply continuity.
• Generate and track supplier performance metrics and provide data-driven recommendations to improve supplier health and performance.
• Support supplier audits, process reviews, and operational assessments as required.
• Partner closely with Manufacturing, Quality, Supply Chain, Planning, Procurement, and Engineering teams to support plant objectives.
• Communicate supplier risks, issue status, recovery plans, and project updates clearly to cross-functional teams and leadership.
• Support New Product Introduction (NPI) activities by evaluating supplier readiness, process capability, validation strategy, and production ramp risk.
• Maintain strong supplier relationships to effectively partner between the organization and the supply base.
• Provide technical recommendations and supplier performance updates with minimal supervision.
• Perform other related duties as assigned.

Skills:

• Strong technical problem-solving and root cause investigation skills.
• Working knowledge of pFMEA, process validation, statistical analysis, SPC, inspection methodologies, and corrective action systems.
• Familiarity with Lean Manufacturing and Six Sigma methodologies.
• Proficiency in Microsoft Excel, Word, and Project.
• Experience with ERP and document management systems such as SAP and Agile preferred.
• Experience with Minitab or statistical analysis software preferred.
• CAD / 3D modeling experience is a plus.

Qualification And

Education:

• Strong analytical, organizational, and communication skills.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.
• Demonstrated ability to work cross-functionally and influence without direct authority.
• Ability to travel domestically and internationally as needed (approximately 25%).
• Knowledge of 21 CFR Part 820 and ISO 13485 preferred.
• Six Sigma certification or Lean Manufacturing certification preferred.
• Experience working directly with external…