Sourcing Engineer

Title: Sourcing Engineer

Pay Rate $70.00/hour - $80.00/hour

Duration: 6 month assignment

Location: Campbell, CA

Experience in all aspects of injection molding including tooling validation, gage R&R, part and inspection specifications and vendor qualification.

Looking for a Sourcing Engineer who is highly technical and capable of bridging the gap between design, manufacturing, and the supply chain

• Tooling Validation: Experience managing the entire lifecycle of injection mold tools. Look for hands-on involvement with DFM (Design for Manufacturability), tool design, sampling, and debugging.
• Process Validations: Demonstrated ability to execute and review IQ/OQ/PQ (Installation, Operational, and Performance Qualification) protocols at supplier facilities.
• Gage R&R (Measurement System Analysis): Proven ability to validate measurement systems, ensuring inspection equipment and fixtures are accurate, repeatable, and reproducible.
• Part & Inspection Specifications: A strong background in interpreting GD&T (Geometric Dimensioning & Tolerancing) and defining clear, measurable cosmetic criteria, part tolerances, and FAIR (First Article Inspection Reports).
• Supplier/Vendor Qualification: Experience identifying, vetting, and developing contract manufacturers and tool shops, alongside executing PPAP (Production Part Approval Process) deliverables and supplier pFMEA.
• Education: B.S. or M.S. in Mechanical, Manufacturing, or Plastics Engineering.
• Industry Experience: 3 to 7 years evaluating, qualifying, and managing plastic injection molding suppliers.
• Software Skills: Familiarity with Minitab (or similar statistical tools) and dimensional inspection/metrology.
• Methodologies: Strong background in Six Sigma and Lean Manufacturing (Cp/Cpk studies, Process Capability, Root Cause Analysis).

Job Summary

The Sourcing Engineer ensures the technical compliance, quality, and scalability of our plastic injection molding supply chain. This role manages global suppliers to deliver high-quality components matching strict medical device requirements. The ideal candidate will blend technical expertise in tooling validation, scientific molding, and statistical analysis with strong supplier qualification skills within a regulated GMP framework.

Core Responsibilities

Tooling Validation & Process Control

• Lead DFM Reviews: Partner with R&D and suppliers to optimize component design for manufacturability, moldability, and cost.
• Manage Tooling Lifecycle: Oversee tool development from initial design approval and sampling through final production sign-off.
• Execute IQ/OQ/PQ: Author, review, and approve critical Installation, Operational, and Performance Qualification protocols at supplier facilities.
• Implement Scientific Molding: Apply decouple molding principles to establish robust, stable, and repeatable manufacturing windows.

Quality, Metrology & Specification Management

• Define Component Specifications: Establish clear inspection criteria, cosmetic standards, and dimensional tolerances using GD&T principles.
• Validate Measurement Systems: Conduct Gage R&R studies to ensure supplier and internal inspection methods are repeatable and reproducible.
• Review Inspection Data: Analyze First Article Inspection Reports (FAIR) and process capability data (\(C_{p}\), \(C_{pk}\)) to verify parts meet strict specifications.
• Manage Risk Assessment: Author and update Supplier Process Failure Mode and Effects Analyses (pFMEA) to mitigate manufacturing risks.

Supplier Qualification & GMP Compliance

• Onboard Vendors: Audit, evaluate, and qualify contract manufacturers and tool shops for compliance with ISO 13485 and 21 CFR Part 820 standards.
• Own PPAP Deliverables: Drive the Production Part Approval Process to ensure suppliers are fully compliant before commercial launch.
• Enforce GMP Standards: Maintain comprehensive, audit-ready technical documentation within the company’s Quality Management System (QMS).
• Drive Root Cause Analysis: Lead technical investigations and Corrective and Preventive Actions (CAPA) for supplier-related material defects.

Education & Experience

• Degree: Bachelor’s degree in Mechanical Engineering, Plastics Engineering, Manufacturing Engineering, or a related technical discipline.
• Experience: Minimum of 5 years of engineering experience in plastic injection molding, tooling validation, and supplier management.
• Regulated Industry: At least 3 years working directly within a Medical Device, IVD, or pharmaceutical manufacturing environment.

Technical Skills

• Standards: Strong operational knowledge of ISO 13485, ISO 14971, and FDA 21 CFR Part 820.
• Statistics: Expert proficiency with Minitab or similar statistical software for Gage R&R, ANOVA, and capability analysis.
• Print Reading: Mastery of Geometric Dimensioning and Tolerancing (GD&T) per ASME Y14.5.
• Travel: Ability to travel up to 25-30% to visit supplier facilities and manufacturing sites.

Benefits (employee contribution):

• Health insurance
• Health savings account
• Dental insurance
• Vision insurance
• Flexible spending accounts
• Life insurance
• Retirement plan

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Rate of pay within the stated range will depend on the qualification of the applicant.

We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act