Product Development Technician

Industry

Engineering

Advert ID

FOX_BBBH31684

Location

Maple Grove

Job Type

Permanent

Hours

Full-Time

Salary Range

USD63000-65000 per year

No. of Openings

1

Branch Information

Minnesota Engineering - (USA) 3600 Minnesota Drive Suite 850 MN Edina , MN 55435 Phone : 612-630-1200

ContactNumber

612-630-1200

Job Description

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)