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Senior Mechanical Engineer

Company: ACIST Medical Systems, Inc.
Location: Eden Prairie
Posted on: September 17, 2021

Job Description:

Insight Global is seeking a Senior Mechanical Engineer for a global Medical Device client located in Eden Prairie, MN. This resource is responsible for participating and/or providing leadership in the mechanical design of new and modified high volume disposable medical devices, accessories, and electromechanical medical devices. They will provide project leadership and execution for all aspects of design and modification to disposables development including requirements and specification creation, perform engineering modeling and analyses, develop test methods and fixtures, document and communicate the design internally and to suppliers. They will work with and through contract manufacturer to produce samples and production level goods. This role requires significant creativity and experience, using engineering practices in the design, analysis and verification of components (injection molded, extruded, machined, sheet metal, etc), assemblies, mechanisms and systems. Candidate must be a self-starter capable of driving challenging projects individually and as a group through a PDP process.

- Advanced degree a plus

- Experience in a regulated medical device industry

- Drawing management system knowledge

- Working knowledge of medical terminology

- Knowledge of QSR, ISO/EN and Quality System Standards

- Project management experience

- Familiar with use of 3D printing and design

- Familiar with cath lab procedures used in diagnostic and interventional cardiac imaging as well as peripheral imaging, TAVR procedures, neuro imaging, and CT/MR imaging.
- BS Mechanical / Manufacturing / Biomedical Engineering

- Working knowledge of finite element analysis, tolerance analysis, and geometric tolerances.

- 8+ years experience as a design engineer developing sterile disposable medical devices, preferably with involvement in electromechanical devices in the medical device space or similar regulated industry.

- Ability to document prospective engineering analysis

- Strong technical writing skills

- Design of injection molded, extruded, machined, formed, sheet metal and other metal/plastic components

- Knowledge of common sterilization processes (gamma, E-beam, EtO, etc)

- Knowledge of common bonding and manufacturing processes such as solvents, UV adhesive, RF welding, etc.

- Proficient in SolidWorks, including drawing creation

- Working knowledge of statistics

Keywords: ACIST Medical Systems, Inc., Eden Prairie , Senior Mechanical Engineer, Other , Eden Prairie, Minnesota

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