NPD Operator - Brooklyn Park, MN
3 days ago
Job description
Company Overview
Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures. We are focused on next generation solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.
At Biomerics, we are dedicated to our diverse employee base. We understand that a strong, skilled, and engaged workforce is the foundation of our continued success as a business. We strive to live up to Biomerics' values in all our interactions. It is an exciting time to be part of our collective team, and there is no limit to the impact that can be achieved here at Biomerics. We improve and advance the lives of our employees and the patients who depend on our products.
At Biomerics, we believe in integrity, partnership, empowerment and accountability, trust, agility, teamwork, and excellence, and we care. Our team-oriented, customer-focused corporate culture prioritizes building strategic, mutually beneficial partnerships with customers and our team members.
Position Summary
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.
Key Responsibilities
Product Development & Assembly
- 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)
Process & Documentation Support
- 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
Testing & Evaluation
- Perform basic functional testing, inspections, and measurements using approved equipment
- Identify and escalate defects, inconsistencies, or nonconformances
- Support root cause investigations and corrective actions
Cross-Functional Collaboration
- 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
Quality & Compliance
- 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
Requirements
Required Qualifications
- 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 Qualifications
- 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
Skills & Competencies
- 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
Physical & Environmental Requirements
- 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
Biomerics offers the following benefits: Medical/Dental/Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, Paid Holidays, 401k, Onsite Fitness Facility
Please, No Recruitment Agency calls or emails (we are not using recruitment services for this or any other role posted)
Salary Description
$23-25
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