Associate Prototype Technician
Integer Holdings Corporation
Summary
Adheres to Integer's Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
Job description
- Constructs engineering samples and prototypes to specifications and requirements with direction from the Engineering team.
- Assists in organization of engineering build notes and documentation from all prototype builds. Supports Engineers in the creation of build documentation.
- Provides value-add feedback to design engineers through post-build reviews, design reviews, and documentation reviews.
- Reads and understands drawings, specifications, schematics, and sketches.
- Supports initial production builds and transition from engineering to production.
- Assembles component parts as per print. Utilizes both manual and automatic machine operation.
- Visually and/or dimensionally inspects parts and/or completed assemblies for conformance to specifications. Completes required Device History Records and other manufacturing documentation per Good Documented Practices (GDP). Identifies and escalates quality non-conformances.
- Sets up equipment needed for assembly/inspection as per work instructions or as dictated by the product configuration.
- Participates in team activities focusing on process/product improvement, problem resolution, and customer satisfaction.
- Performs other duties as required.
Education & Experience
- Minimum Education: High school graduate or equivalent.
- Minimum Experience: 3 years catheter-related work experience and/or 3-5 years light assembly experience in a regulated industry required; medical device experience preferred. Associate's degree or above with a minimum 0-3 years of experience.
Knowledge & Skills
- Special Skills: Excellent communication skills required. Familiarity with microscopes and measuring devices required.
- Certification for industry specific assembly requirements such as IPC soldering standards for the medical device and Military markets desired.
- Technical training in welding, material science, and one-year related quality experience preferred.
- Specialized Knowledge: Ability to read, comprehend and follow detailed instruction and/or available documentation.
- Must possess the ability to recognize obvious defects in workmanship.
- Demonstrates competency in multiple critical assembly processes.
- Demonstrate ability to be flexible; work independently and in a production-line setting and in multiple locations within the facility.
- Ability to work with a variety of equipment and instruments such as Hot boxes, Ovens, Split die bonders, Cath-Tip/tipping machines, Soldering irons, and Injection Molders.
- Knowledge in Microsoft Office products.
Requirements
- High school graduate or equivalent
- 3 years catheter-related work experience and/or 3-5 years light assembly experience in a regulated industry
- Excellent communication skills
- Familiarity with microscopes and measuring devices
- Ability to read, comprehend and follow detailed instruction and/or available documentation
- Ability to recognize obvious defects in workmanship
- Competency in multiple critical assembly processes
- Ability to work independently and in a production-line setting
- Ability to work with equipment such as Hot boxes, Ovens, Split die bonders, Cath-Tip/tipping machines, Soldering irons, and Injection Molders
- Knowledge in Microsoft Office products
Benefits
- Medical, Dental & Vision
- Disability Insurance
- Life Insurance
- Adoption Benefits
- Parental Leave
- 401(k) Matching
- Paid Time Off
- Holiday Pay
- Cash-based Incentive Program
Company overview
Integer Holdings Corporation (NYSE: ITGR) is one of the world's largest medical device contract development and manufacturing organizations (CDMO), serving as a strategic partner to leading medical device companies and OEMs globally. With an 80-year legacy of innovation, the company specializes in advanced medical device outsourcing across cardiac rhythm management, neuromodulation, and cardio and vascular markets. Integer operates through its two primary brands, Greatbatch Medical® and Lake Region Medical®, offering comprehensive solutions from product design and development to finished device manufacturing. The company's extensive product portfolio includes catheters, guidewires, delivery systems, implantable batteries, capacitors, and Class III medical devices, serving over 15 medical markets. With manufacturing facilities spanning four continents and more than 2.5 million square feet of production space, Integer provides vertically integrated supply chain solutions that help medical device companies accelerate time-to-market while maintaining uncompromising quality and regulatory compliance standards.