Design Quality Engineer

Location: Northridge

Reference: 628947

Posted:

Location:

Northridge, California Company:
Planet Pharma Group Contact:
Applications Email: applications

Pay 50-60/h depending on experience“Design Quality Engineer — Process Development to support new product introduction (NPI) and production scale-up activities within the diabetes medical device space. This individual will drive process validation strategies, lead process risk management (PFMEA), and serve as a critical cross functional liaison between internal Supplier Quality, R&D, Contract Manufacturers, and NPI teams. The ideal candidate brings deep expertise in process development, FMEA methodologies, and regulatory compliance –A proven track record of resolving critical production issues during scale-up and mentoring engineering teams is essential.
Process Development & Validation

* Develop P-diagrams, Input-Process-Output (IPO) matrices, process characterizations, and test method validation (TMV) strategies for NPI programs.

* Author and manage Master Validation documents (IQ/OQ/PQ/EQV/TMV) for new product introductions and production scale-up.

* Apply methodologies including Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), Design for Manufacturing Assembly (DFMA),
and Cell Operating System (COS).

* Drive risk mitigation approaches by integrating qualification parts early in process development phases
Process Risk Management & Risk Navigation

* Facilitate and generate Process Failure Modes Effects Analysis (PFMEA) documents for manufacturing processes during NPI and scale-up.

* Maintain strong working knowledge of design risk documentation (RAD, DFMEA, HRA) to critically analyze process-related failures and identify gaps.

* Recognize when process findings have design risk implications and escalate appropriately to Design Quality Assurance (DQA) partners for design risk
assessment decisions.

* Leverage understanding of risk documentation during root cause investigations and critical analyses to ensure comprehensive disposition.

* Conduct thorough root cause investigations using A3 Problem Solving methodology, fishbone diagrams, 5-Why analysis, and brainstorming techniques
Cross-Functional Engagement & Collaboration

* Serve as the primary quality interface between internal Supplier Quality Engineering (SQE), R&D cross-functional teams, Contract Manufacturers, and NPI
program teams

* Facilitate regular cadence of alignment discussions with Supplier Quality and vendors to implement updated control plans, inspection criteria, and risk
documentation.

* Collaborate with R&D teams to translate design intent into manufacturable process parameters during design transfer

* Partner with NPI groups to ensure seamless transition from development builds through production qualification and commercial readiness.

* Ensure alignment between contract manufacturers and internal teams on deliverables, expectations, and quality standards.

* Bridge QMS gaps between contract manufacturing partners and internal quality systems, standardizing documentation templates and expectations.

* Direct comprehensive drawing reviews with cross-functional partners ensuring all Critical Dimensions are accounted for incoming and in-process inspections.
Production Scale-Up Support & Crisis Management

* Lead cross-functional teams through high-pressure production holds and scale-up challenges during NPI commercialization.

* Conduct root cause investigations (A3 methodology) and implement Corrective and Preventive Actions (CAPA).

* Strategize and guide engineering teams to deploy effective investigation approaches for supplier and manufacturing issues.

* Proactively identify production risks during scale-up and drive containment/resolution before they impact launch timelines.
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