Quality Assurance Engineer/ Process Engineer (US / Green Card)

Job DescriptionJob Description

Job TItle : Quality Assurance Engineer/ Process Engineer (US / Green Card)
Location : Maple Grove, MN
Type : Onsite
Duration : 12 Months with ext

Job Description:
The Design Assurance Engineer will interface with R&D and other supporting cross-functional teams on developing and maintaining medical equipment, including software and cybersecurity elements.
Design assurance drives the ISO 14971 risk management process, Verification & Validation (V&V) process.
This includes quality plans, risk management plans and reports, hazard analysis, product risk management workbook (user FMEA and design FMEA), sampling systems/procedures and statistical techniques, verification protocols/testing/reports, validation protocols/testing/reports.
Interfaces with all other quality and engineering components within the company and with customers and suppliers on quality-related issues.Actively participate in all aspects of Design Control, including capital equipment, systems, and software. Serves as a quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional, and corporate quality goals and priorities.

Key Responsibilities:
• Support the execution and documentation of Design Validation & Verification and Usability activities.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization.
• Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification and Component Specifications).
• Update and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs).
• Lead and support cross-functional root-cause analysis investigation and resolution activities
• Evaluate and support design test and inspection method development, and lead method validation activities
• Support regulatory submissions to notified bodies.
• Understanding of technologies incorporated into design.
• Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Minimum Qualifications:
• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering or Electrical Engineering.
• 2+ years of experience in design assurance, quality, new product development, or related medical device / regulated industry experience
• Problem solver, capable of facilitating the problem-solving process
• Adaptable and effective collaborator in a team environment and in self-directed work
• Strong communication skills (verbal & written)
• Ability to work in a highly matrixed and geographically diverse business environment
• Demonstrated use of Quality tools/methodologies qualifications:
• Previous Software or Capital equipment Design Assurance experience is a plus
• Medical device or other regulated industry experience
• Strong knowledge of Quality System Regulation (QSR), Risk Management standards (ISO 14971) and software standards (IEC 62304 or IEC 82304)
• Experience with 60601, software and cybersecurity
• Experience working in an Agile environment