Quality Engineer

Please send the resumes to careers@starkassociatesllc.com or

Contact: + 848-300-0022

Job Title: Quality Engineer

Location: West st paul,MN

Duration: 12+ Months

Job Description:

Key Responsibilities

Support the development of critical care devices or subsystems thereof from concept to commercial launch

Apply engineering principles to the design of electro mechanical medical devices, effectively use tests and simulations to expedite development in a fast paced environment

Design, prototype and test components of medical devices, develop new test methods to evaluate devices

Work with internal and external resources to contribute to the design and development, testing and release of electromechanical components used in medical device systems

Solve technical issues working as a contributing member of a diverse engineering team

Integrate development of medical technology by assuring the design of technology interfaces and system elements works together as a whole

Write design verification and validation protocols and reports in accordance with quality procedures assuming full ownership as the Study Director

Provide solutions to the technical aspects of product design and development as well as the translation of marketing requirements into product specifications

Work with R&D technical teams (Mechanical, Electrical, Systems, Software) and internal partners in the Marketing, Regulatory, Quality, Clinical, Manufacturing and other departments to deliver project objectives.

Education And Experience

Bachelor’s Degree in Mechanical Engineering with 0-2 years experience (Master’s or PhD degree lessens the experience required for the position)

Must have good 3D CAD skills in SolidWorks.

Working knowledge of basic statistics and six-sigma principles

Requires strong technical aptitude, leadership, communication, writing and coordination skills

Requires a high-energy individual who has excellent teamwork, partnering, and negotiation skills

Must be a highly motivated self-starter who is able to achieve results with minimal direction

Must be proactive and creative in achieving goals

Must have strong conflict resolution skills:

Additional Skills

Previous mechanical design experience with disposable devices, capital equipment, and/or sensors (pressure, flow, optical).

Proficiency in mechanical design, tolerance stack-up analysis, design for Manufacturability (DFM), and specification development

Experience in design verification & validation within an FDA regulated industry

Experience with design control procedures

Experience with Solidworks, LabView, MatLab, and quantitative analysis of data

Knowledge of relevant manufacturing processes like injection molding, extrusion etc.

Comfortable in a dynamic working environment with multiple priorities