NPD Engineer II

SMC Ltd.•Santa Rosa, CA

About The Position

The NPD (new product development) Engineer II performs multiple related duties in conjunction with other employees and departments contributing to the overall team effort, efficient process, and safe working environment. This position includes many essential components necessary for successful and efficient manufacturing, and as such, shares full responsibility for the final product delivered to the customer.

Requirements

Bachelor’s degree in mechanical engineering, manufacturing engineering, industrial engineering, or related engineering degree.
2+ years of experience in contract manufacturing; will consider recent college graduates if they have related internship experience.
Strong understanding of mold design principles, mold flow analysis, and plastic part design.
Strong project management and communication skills. This is a client facing role.

Nice To Haves

Background in injection molding industry.
Knowledge of lean manufacturing, Six Sigma, or continuous improvement tools.
Experience in regulated industries (medical, medical device, pharma).

Responsibilities

Leads the transfer of new medical device products and manufacturing processes from development into high‑volume production.
Partners cross‑functionally with R&D, Manufacturing Engineering, Quality, Supply Chain, and customers throughout the NPD lifecycle.
Drives Design for Manufacturability (DFM) and Design for Assembly (DFA) for injection‑molded components and assembled devices.
Supports tooling, mold design, fixturing, work‑cell layout, and automation development for scalable manufacturing.
Develops, implements, and validates manufacturing processes for molded components and assemblies.
Defines and executes validation strategies, including IQ, OQ, PQ, PPQ, and MSA, in compliance with regulatory requirements.
Authors and maintains manufacturing documentation, including work instructions and Device Master Records (DMR).
Ensures compliance with ISO standards, FDA regulations, and internal quality systems.
Manages Release‑to‑Manufacturing activities to ensure production readiness, timeline adherence, and risk mitigation.
Identifies process, equipment, and automation improvements to enhance quality, efficiency, and cost performance.
Applies Lean Manufacturing and Six Sigma principles to support robust and repeatable product launches.
Provides technical troubleshooting support during NPD builds and ongoing production.