Biomerics · 1 day ago
NPD Operator
Biomerics is a world-class manufacturer specializing in innovative polymer solutions for the medical device and biotech industries. The NPD Operator supports the development, testing, and early production of medical devices by building and evaluating prototype products while ensuring compliance with regulatory and quality standards.
BiotechnologyHealth CareLaserManufacturingMedical Device
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
Qualification
Required
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
Preferred
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
Benefits
Medical/Dental/Vision Insurance
Short-Term Disability
Long-Term Disability
Life Insurance
Paid Vacation Days
Paid Holidays
401k
Onsite Fitness Facility
Company
Biomerics
Biomerics is a medical devices company providing polymer solutions.
H1B Sponsorship
Biomerics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (1)
2022 (1)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2023-05-17Series Unknown
2023-05-17Acquired
Recent News
Precedence Research
2025-11-07
2025-10-06
Company data provided by crunchbase