NPI Quality Engineer

NPI Quality Engineer

Summary

Title : NPI Quality Engineer

ID : 2903

Department : Quality

Location : New Richmond, WI

Description

Founded in 1990 and based in New Richmond, WI, Isometric's vision was to manufacture tooling and provide manufacturing solutions to exacting specifications for ultra-small, ultra-precise, and ultra-complex applications. For the past 35 years, we're proud to say we've grown to be one of the largest medical-focused micro molders in the United States. In March 2024, Isometric was acquired by Nissha Medical Technologies (NMT) , a global Contract Design / Development Manufacturing Organization. NMT’s expertise in the design and development of endoscopic devices, combined with Isometric’s market leading micro-molding capabilities, are revolutionizing drug delivery and medical devices including minimally invasive surgical instruments and surgical robotics. Together, we aim to meet the evolving needs of medical devices, enhance component miniaturization, and improve the maneuverability of small and precision components, ultimately contributing to improved device functionality.

It's an exciting time to join our team, and we're hiring for a NPI Quality Engineer . This position serves as a key quality leader supporting the introduction of new medical products through development, validation, and transfer to manufacturing. This role partners with internal teams and clients to ensure product and process development aligns with regulatory requirements and quality system standards, supporting a right-first-time product launch. This is an exempt paid position, and the hours for this position are Monday-Friday, 8 : 00AM-5 : 00PM.

Essential Functions and Responsibilities :

Serve as the primary Quality representative on New Product Introduction (NPI) project teams, collaborating with Engineering, Manufacturing, Regulatory, and clients to ensure quality is integrated from project kickoff through commercialization.

Support or lead the planning, execution, and documentation of validation activities including IQ / OQ / PQ for equipment, processes, and test methods.

Review development measurement methods and inspection results for appropriateness and robustness as part of the NPI process. Reviewer and final approver of new measurement methods.

Lead the execution of First Article Inspections (FAIs), Gage R&R, correlation activities, and capability analysis as part of the NPI process.

Review and approve product documentation including specifications, control plans, drawings, procedures, and records to ensure quality and regulatory compliance.

Collaborate with Supply Chain and Supplier Quality teams to qualify new suppliers, define quality requirements, and ensure incoming components meet specifications.

Evaluate and support change controls and risk management activities related to materials, processes, or specifications during development and launch phases.

Serve as a quality liaison with clients during technical reviews, audits, and project milestones; support regulatory inspections as needed.

Identify and drive opportunities for quality system and process improvements within the NPI framework.

Work directly with Project Engineers in the development of new projects from quotation support, through development and validation of molds, equipment, software, manufacturing processes, and successful transfer to Production.

Ensure that mold, process, and assembly testing is performed in a manner that provides thorough development and a robust manufacturing process.

Assist in development of validation or test method protocols and summary reports.

Work with customers to understand and align all quality requirements established.

Draft and document quality procedures, instructions, inspection methods, control plans, and other product related documentation.

Mitigate product risk through the use of risk management tools.

Support, mentor and train GDP, GMP and Lean Manufacturing best practices.

Use root cause analysis and manufacturing best practices to close all assigned customer complaints and corrective actions.

Supports Isometric ISO13485 continuous improvement initiatives.

Other duties as assigned.

Education and / or Experience :

Bachelor’s degree in Engineering / Quality and a Minimum of 5 years of related medical device manufacturing experience or

Minimum of 7 years’ experience in engineering, project management, or quality in medical device manufacturing

Experience with GD&T and blueprint reading

Experience application in use of metrology equipment such as a Vision System, CMM, Digital Micrometer and Caliper, Microscope, and CT scanner

Strong knowledge and experience with plastics and injection molding processes

ISO13485 and FDA knowledge and experience

Isometric offers a comprehensive benefit package along with competitive pay :

401(k) program with Company match available after 90 days

3 weeks of paid time off, 2 personal days, and 11 paid holidays (10 observed holidays + 1 floating holiday of your choice)

Medical, Dental, and Vision options available the 1st of the month followed by your hire date. Health Savings Account options available including a quarterly company contribution

Company paid coverages include Employee Life / AD&D & Short-Term Disability

Voluntary benefit options include Long-Term Disability, Supplemental Life / AD&D for Employees, Spouse, and Children, Group Accident Insurance, Home Warranty coverage, Legal support coverage, and Pet insurance!

Hands on training

Isometric, a NMT Company, is an Equal Opportunity employer. We are committed to creating a diverse workforce; we support a work environment where colleagues are respected and given the opportunity to perform to their fullest potential. We consider all qualified applicants without regard to race, religion, color, sex, national origin, age, sexual orientation, gender identity, disability or veteran status, among other factors.