Component Engineer

Component Engineer 3

Location:

Sunnyvale, CA (Onsite)

• Complete project/part qualification deliverables including Supplier pFMEA, process validations (IQ/OQ/PQ), inspection reports, Gage R&R, and process capability analysis.
• Work with suppliers to execute cost reductions, capacity improvements, and risk mitigation.
• Select the right process and supplier for the part, considering long‑term fit and total cost of ownership.
• Manage supplier changes including manufacturing process changes, production optimization, facility changes, new equipment qualification, and new line validations.
• Initiate and manage changes to specifications and drawings through the engineering change order process.
• Own and drive closure of supplier variances from symptom through root‑cause analysis to corrective action, including careful CAPA documentation.
• Prioritize and advance multiple concurrent projects and tasks effectively.
• Communicate project status clearly to key stakeholders.
• Build, own, and relentlessly pursue a vision for developing suppliers.
• Maintain proper documentation detail for tracking actions and justifying decisions.
• Generate key metrics for the team and suppliers and drive timely achievement of those metrics.
• Drive suppliers to continually improve their business and manufacturing process performance to meet supplier excellence standards using best practices in project management, Six Sigma, Lean, SPC, and negotiation.
• Lead these efforts without managerial guidance at multiple suppliers simultaneously.
• Implement corrective and preventive actions for supplier processes by driving investigations and root‑cause analysis.
• Provide effective and timely supply‑base health information and recommendations to management by creating and delivering data‑driven reports at any level of management.
• Prepare and deliver supplier communications as required, independently working with suppliers on scorecard creation.
• Work with suppliers and design engineering for new product introduction to create supplier landscapes, determine launch readiness, develop ramp‑readiness plans, and provide DFM feedback to improve manufacturability before production.
• Influence and guide design engineering in choosing suppliers by determining selection criteria for preferred suppliers and leading the evaluation effort.
• Review, analyze, and close customer complaints, manufacturing variance requests, and first‑article inspections, judging risk analyses and justifications.
• Evaluate corrective and preventive actions at suppliers, looking for opportunities to eliminate recurrence.

• Minimum 3 years of related experience in engineering and manufacturing of precision sheet metal, CNC‑machined metal, or plastic injection‑molding parts.
• Excellent written and verbal communication skills, including presentations to executive‑level management.
• Excellent interpersonal and team‑building skills.
• Proven history of implementing Lean, Six Sigma, and SPC programs at suppliers.
• Excellent project management skills.
• Excellent analytical and problem‑solving skills with good judgment.
• Demonstrable knowledge in evaluating and challenging supplier technical, quality, and business capabilities.
• Demonstrable knowledge of a wide range of manufacturing processes, including key input variables for quality, cost, and capacity (specialization may be in metal fabrication, plastics, electronics, and/or contract manufacturing).
• Excellent knowledge of 21
  
  CFR part
  820 and ISO
  13485.
• Significant computer experience using Windows, Word, Excel, Project, Access, and ERP systems, preferably SAP or Agile.
• Ability to read and interpret detailed mechanical drawings (GD&T) and communicate technical information.
• BS degree in engineering or equivalent experience; advanced degree preferred.

• Experience in a high‑volume medical device company.
• Supplier management experience.
• CAD experience with 3‑D modeling tools.
• Experience with statistical analysis software such as Minitab.

Job Type: Contract

Pay Rate: $50‑$60 per hour

• Competitive salary.
• Insurance plan options (HDHP or POS).
• Education and certification reimbursement.
• Pre‑tax commuter benefits.
• Paid Time Off (PTO).
• Administered 401(k) plan.