- 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.
- 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.
- 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.
- 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 of 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.
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Associate Prototype Technician - Plymouth, United States - Integer Holdings
Description
By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.
At Integer, our values are embedded in everything we do.
Customer
We focus on our customers' success
Innovation
We create better solutions
Collaboration
We create success together
Inclusion
We always interact with others respectfully
Candor
We are open and honest with one another
Integrity
We do the right things and do things right
Job Summary
The primary purpose of this role is to perform assembly and inspection operations over a range of new products and/or processes. Will support non-cyclical work which may include prototypes and pre-production lots in preparation for validation, clinical trials or transfers. Will also support multiple builds within the facility including lab and cleanroom environments. With guidance from Engineering on projects and using work procedures, this role provides support to the Engineering teams to meet various deadlines. May provide support to other team members or provide input to the Engineers on assembly, processes, and build/quality documentation.
Accountabilities & Responsibilities
Education & Experience
Knowledge & Skills
U.S. Applicants: EOE/AA Disability/Veteran
Equal Opportunity Employer, including Disability/Veterans
