Senior NPI Engineer

Job Description

Job Description

Senior NPI Engineer Location: Irvine, CA 92618 (Onsite) Employment Type: Contract (13 months) Pay Rate: $87/hour Start Date: ASAP – flexible to start mid-week if needed

ATR International is seeking a Senior NPI Engineer on behalf of our client, Diality, a medical device company focused on developing solutions to improve lives impacted by kidney disease. Diality offers the Moda-flx Hemodialysis System, a user-friendly, mobile, and connected hemodialysis system designed to maximize clinical flexibility and ease-of-use for both clinical and non-clinical users. The Moda-flx system combines the flow rate capabilities of conventional in-center dialysis devices with a fully integrated reverse osmosis (RO) water filtration system to provide a broad range of prescriptions and meet the needs of any professional dialysis care setting.

About the Role

The Senior NPI Engineer will lead the successful transfer of new medical device products from Research & Development into commercial manufacturing. This position provides technical leadership in manufacturing process development, injection molding, mold design, tooling validation, equipment qualification, and production readiness. The engineer will work cross-functionally with R&D, Quality, Regulatory, Supply Chain, Tooling Suppliers, and Operations to ensure products are designed for manufacturability, regulatory compliance, quality, and cost-effective production.

A strong background in plastic injection molding, mold design, mold qualification, scientific molding, and process validation is essential.

Responsibilities

• Lead manufacturing engineering activities for new product development and commercialization.
• Drive Design for Manufacturability (DFM) and Design for Assembly (DFA) reviews throughout product development.
• Develop manufacturing strategies from prototype through high-volume production.
• Coordinate engineering builds, pilot production, design verification, process validation, and production launch.
• Manage technology transfers from R&D to manufacturing and contract manufacturers.
• Collaborate with design, quality, manufacturing, and vendors to define test requirements and ensure test coverage.
• Implement automated test solutions to improve efficiency, accuracy, and scalability in production environments.
• Provide technical support to manufacturing and operations teams to resolve issues.
• Lead development of injection molding processes for precision medical device components.
• Collaborate with Product Development and mold suppliers to design production injection molds.
• Participate in design transfer activities.
• Lead mold design reviews with external mold manufacturers.
• Support mold fabrication, FAT, SAT, mold sampling, and qualification activities.
• Approve mold modifications to improve quality, productivity, and manufacturability.

Required Skills & Abilities

• Strong problem-solving skills and attention to detail.
• Extensive experience with precision plastic injection molding.
• Good documentation skills with strong communication and teamwork abilities.
• Strong knowledge of GD&T, engineering drawings, tolerance stack-up analysis, and geometric dimensioning principles.
• Experience with New Product Introduction (NPI), product commercialization, and technology transfer from R&D to manufacturing.
• Knowledge of FDA-regulated manufacturing environments.
• Hands-on knowledge of scientific molding.
• Proficiency with engineering tools such as Minitab, Moldflow, and CAD software (e.g., SolidWorks, Creo, or NX).

Education & Experience

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Plastics Engineering, or a related engineering discipline.
• 7-9+ years of manufacturing engineering experience in the medical device industry.
• 5+ years of experience supporting New Product Introduction (NPI) programs.
• Demonstrated experience supporting new product launches, pilot builds, engineering builds, and production ramp-up in a regulated manufacturing environment.
• Experience developing and executing IQ/OQ/PQ, process validations, equipment qualifications, and manufacturing readiness activities.
• Strong background in Design for Manufacturability (DFM), Design for Assembly (DFA), process characterization, and Design of Experiments (DOE).
• Experience leading tooling development from concept through production release.
• Experience working closely with vendors and contract manufacturers.
• Experience within a highly regulated medical device industry.

Travel

• Up to 25%, could be more during pilot production launch at contract manufacturer.

Physical Requirements / Working Environment

• Ability to lift up to 40 lbs.
• Office, engineering, and controlled build labs environment; requires frequent sitting, standing, and walking.

Candidates must be legally authorized to work in the United States on a W2 basis for the duration of this contract. Visa sponsorship is not available for this position.

ATR International is an Equal Opportunity Employer.

ATR International is a staffing and workforce solutions firm providing high‐quality talent across a wide range of industries, including technology, operations, and professional services.

Company Description

ATR International is a staffing and workforce solutions firm providing high‐quality talent across a wide range of industries, including technology, operations, and professional services.