POSITION: Design Assurance Engineer
FULLTIME: ASAP start with 12-month contract (potential temp to hire based on performance)
LOCATION: Chandler, AZ (hybrid Mon & Fri work from home)
SCHEDULE: Monday - Friday; 8:30am - 5pm
PAY RANGE: $44.54 - $56.87/hr paid weekly

Details:

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

Preferred 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

Working Conditions:

• May on occasion be exposed to loud sounds and distracting noise levels, such as from office equipment.
• The ability to lift up to 30lbs.
• Use of computers and technology

Here at Canon Recruiting, People are our priority, and we are committed to Include Diversity in every segment of who we are. It is only through our Diversity; we are made a stronger organization and increase our ability to provide top tier candidates that our clients have come to know Canon for. We have an inclusive environment all employees are celebrated for their unique differences. The different perspectives and experiences of our workforce give us the competitive advantage that is essential for success in an ever-changing market. By promoting inclusion with the same enthusiasm, we devote to quality and competency and using the experience from a diverse assortment of backgrounds and experiences, Canon is able to improve the services and value we deliver to clients, employees, and customers. At Canon, Diversification and Inclusiveness are much more than a corporate ambition; they are a critical component in our daily corporate life. Canon Recruiting is committed to a diverse and inclusive workplace. Canon Recruiting is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. The pay range for this position is listed above. Base pay information is based on market location. We will consider for employment qualified applicants with arrest and conviction records. Our range of benefits may include health care and 401(k) savings plans. For individuals with disabilities who would like to request an accommodation, please email our HR team hr@canonrecruiting.com