Product Development Technician OR Manufacturing Technician | Direct Hire | Up to $63k yearly | Maple Grove, MN | Medical Device Industry
DUTIES:
Design, prototype, and test components and sub-assemblies to meet product objectives, including tooling, test stations and fixtures.
Contribute to the design and development of new minimally invasive and orthopedic products, under the direction of R&D engineers.
Assist in writing procedures, specifications, and reports.
Utilize established mathematical and scientific techniques to compile and analyze data with common analytical software such as Excel or Distribution Analyzer.
Apply both technical intuition and analytical rigor and constructively provide critical technical assessment of their own and other's work.
Cross-train other team members when required.
Perform duties in accordance with established procedures, including good documentation practices.
Interact with internal teams to explore, troubleshoot and improve designs, fabrication processes and procedures.
Create 3D models of products, components, and tools, as needed.
Print prototypes and tools on 3D printer.
Performs other duties as needed. Quality Systems
Perform various quality assurance tasks such as review of quality records, including lot history records, and returned product records.
Create and update quality system documents such as systems procedures in accordance with ISO 13485:2016 and FDA regulations.
Maintenance of quality system records and files as required.
Assist or perform investigations such as CAPA or Nonconformance investigations.
Perform review of quality records to ensure GDP requirements are met. Quality Inspection Support
Performs visual and dimensional inspections and evaluations of components and devices according to product specifications.
Complete First Article Inspections and supporting documentation
Maintain accurate and up to date records of all materials. These activities are conducted during incoming receiving, in-line inspections, returned materials, etc.
Assist in the development and improvement of product assurance systems such as incoming and in-process quality control, statistical process control, nonconformity controls, product lot release testing, and finished goods control. Operations Support
Assembles product in a production environment in the cleanroom and in the lab, as directed by his/her manager.
Perform preventive equipment maintenance tasks as directed by operations.
Perform other routine operations functions as directed by operations.
Perform weekly Product Processing Area cleaning as well as keeping daily lab tidiness and cleanliness.
Assist in managing the inventory control system.
Assist in performing receiving activities.
Creates and performs calibration procedures for in-house calibration activities, as directed by engineering.
QUALIFICATIONS:
Med device, Sr. Operator or Tech or Associate Engineer level role Balloon catheter/balloon bonding Coil & braided shaft liner stretching Manual brake Well versed in reinforced shaft (PET Heat Shrink)
