NPD Operator

Biomerics•Brooklyn Park, MN

About The Position

The New Product Development (NPD) Operator supports the development, testing, and early production of medical devices by building, assembling, and evaluating prototype and pilot-stage products. This role partners closely with Engineering, Quality, and Manufacturing teams to ensure new products are built accurately, documented correctly, and transitioned smoothly into production while maintaining compliance with regulatory and quality standards.

Requirements

High school diploma or GED required
1–3 years of experience in manufacturing, assembly, or medical device production preferred
Experience following detailed work instructions and documentation
Strong attention to detail and ability to work with precision
Ability to read and interpret basic drawings, specifications, and procedures
Manual dexterity and mechanical aptitude
Strong documentation and organizational skills
Ability to communicate issues clearly
Comfortable working in a fast-changing, development-focused environment
Team-oriented with a continuous improvement mindset
Ability to sit or stand for extended periods
Ability to perform repetitive tasks and fine motor movements
Ability to work in a cleanroom environment and wear required PPE

Nice To Haves

Experience in a medical device, life sciences, or regulated manufacturing environment
Exposure to NPD, R&D builds, pilot production, or product launches
Experience in catheter shaft reflow and assembly
Cleanroom experience
Familiarity with GMP, ISO, or FDA-regulated environments

Responsibilities

Build and assemble prototype, pre-production, and pilot medical devices following engineering instructions, drawings, and specifications
Support design verification and validation builds (DV/DV, PV, pilot runs)
Perform manual and semi-automated assembly processes in a controlled environment (cleanroom as required)
Follow work instructions, SOPs, travelers, and build records accurately
Document build activities, issues, and deviations clearly and in real time
Provide feedback to Engineering on build challenges, manufacturability, and process improvements
Perform basic functional testing, inspections, and measurements using approved equipment
Identify and escalate defects, inconsistencies, or nonconformances
Support root cause investigations and corrective actions
Partner with Engineering, Quality, and Manufacturing teams during development and transfer activities
Participate in build reviews, pilot run debriefs, and process improvement discussions
Assist with training Manufacturing Operators during product transfer, as needed
Maintain compliance with FDA, ISO 13485, GMP, and company quality system requirements
Ensure proper handling of materials, components, and devices
Follow safety, EHS, and cleanroom protocols