Design Quality Engineer - Hire Road : Job Details

Job Description

Design Quality Engineer

Wauwatosa, WI

Summary:

Our client is a nationwide leader in healthcare technology, looking for a Design Quality Engineer. The Design Quality Engineer will utilize and maintain quality engineering systems and practices in collaboration with their manufacturing and design centers that meet and exceed internal, customer, and regulatory requirements.

The Design Quality Engineer will have a bachelor's degree in engineering with 3-7 years of experience in the medical device space.

Design Quality Engineer Job Requirements:

• Bachelor's Degree (BS) in Engineering, Scientific, or Technical related subject required
• 3-7 yrs. of relevant experience, preferably in Design and Development in an ISO13485, FDA 21CFR820 and MDSAP regulated environment, mainly for the Design Controls process and requirements
• ISO13485 and FDA 21CFR820 highly desired
• Working knowledge and experience with metrology labs preferred and GD&T
• Experience with medical device ISO14971 Risk Management.
• Previous working experience in a Design Quality Assurance role for medical device equipment is required
• Working knowledge of IEC 60601-1 Safety standards preferred, but not required
• Use of statistical analysis software for SPC & CPk Analysis
• Tooling and fixturing development and qualification (FAI and Gage R&R)
• Minimum 3 years of working experience with Corrective and Preventive Actions at the Design and Development phase of a product lifecycle
• Proficient computer skills in MS Office Suite, including MS Project and Visio
• Working knowledge of CAD software preferred (i.e., SolidWorks, Autodesk, etc.)
• Strong analytical skills and attention to detail
• Strong technical writing skills and effective communication skills
• Strong presentation, facilitation, and project management skills
• High level knowledge of DFSS concepts and tools preferred, but not required

Design Quality Engineer Job Responsibilities:

• Acts as a team member in supporting quality decisions and practices
• Applies systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Applies statistical methodologies for assessment and to resolve potential product and quality system issues
• Develops and maintains or supports the development of testing plans, models and methods for raw materials, materials in process, and finished goods
• Collaborate with Design, Manufacturing, and Supply Chain teams ensuring adequacy of product specifications to select and monitor suppliers
• Coordinates planning and execution of first article inspections and approvals
• Coordinate planning, execution and maintenance of tooling verification and validations in conjunction with manufacturing and engineering teams
• Leads activities to support medical device manufacturing, such as Risk Management, Process FMEA, and Quality Control Plans
• Plans, develops, and oversees execution of Design verification and validation protocols
• Leads advanced product quality planning activities and assists in preparing new product designs for certification testing
• Participates in projects and cross functional teams and possibly leading mid-scale projects

WHO WE ARE

Choosing the Hire Road is about shared success, active and committed partnerships and relationships that last. Hire Road is solely focused on connecting highly skilled professionals with leading organizations. We are a solutions-based, results-oriented staffing company specializing in a wide range of industry specific practices. To put it simply, we recruit, screen and hire talented people for temporary and full-time positions.

This classification description is intended to indicate the general kinds of tasks and levels of work difficulty that are required of positions given this title and should not be construed as declaring what the specific duties and responsibilities of any particular position shall be. It is not intended to limit or in any way modify the right of any supervisor to assign, direct and control the work of the employees under her/his supervision. The use of a particular expression or illustration describing duties shall not exclude other duties not mentioned that are of a similar kind or level of difficulty.

Equal Opportunity Employer