Component Engineer

Cynet Systems•Sunnyvale, CA

17h

About The Position

The Component Engineer will serve as the primary technical interface between plant manufacturing teams and suppliers. This role is responsible for addressing quality issues, line disruptions, yield loss, delivery concerns, and capacity constraints. The engineer will lead supplier issue resolution, support manufacturing operations by resolving deviations and nonconformances, and monitor supplier performance to drive improvements. A key aspect of this role is proactively managing supplier risks to ensure uninterrupted production. The engineer will collaborate with suppliers to enhance manufacturing processes, improve process capability, and strengthen process controls. Utilizing structured problem-solving methodologies and data-driven analysis, the engineer will drive sustainable corrective actions and investigate recurring defects and inefficiencies. This role also involves developing and executing supplier development plans, owning supplier qualification and validation activities, and managing supplier process changes. Supporting New Product Introduction (NPI) and production scaling is crucial, including assessing supplier readiness and capability. The Component Engineer will convert recurring supplier issues into structured improvement initiatives and drive continuous improvement projects focused on quality and operational efficiency. Generating and tracking supplier performance metrics, supporting audits, and partnering closely with internal teams are also key responsibilities. Clear communication of supplier risks, issue status, and project updates to cross-functional teams and leadership is essential. Maintaining strong supplier relationships and providing technical recommendations with minimal supervision are expected.

Requirements

Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or equivalent technical discipline.
Minimum 2+ 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.
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.
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%).

Nice To Haves

Hands-on experience with manufacturing processes such as machining, MIM, injection molding, stamping, extrusion, or assembly processes.
Experience supporting New Product Introduction (NPI) and production scaling.
Experience with ERP and document management systems such as SAP and Agile.
Experience with Minitab or statistical analysis software.
CAD / 3D modeling experience.
Knowledge of 21 CFR Part 820 and ISO 13485.
Six Sigma certification or Lean Manufacturing certification.
Experience working directly with external suppliers and contract manufacturers.
Experience supporting production issue escalation and supplier recovery activities.

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, 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.