Sustaining Systems Design Quality Engineer II
Job Description
Job Description
POSITION: Sustaining Systems Design Quality Engineer II
FULLTIME: 12-Month Assignment (Possible temp to hire for right individual and if budget allows.)
LOCATION: Maple Grove, MN (Hybrid)
SCHEDULE: 8AM-4:30PM
PAY RANGE: $35-42/HR
(Exact compensation may vary based on skills, experience, and location. Base pay information is based on market location.)
JOB DESCRIPTION:
The Design Quality Engineer II will support application of design controls to projects focusing on design changes, material continuity, regulatory and standards compliance, corrective and preventive actions, and improvements for manufacturability and cost reduction. This individual will work with a high performance cross-functional team to ensure safety, quality, and compliance of products.
Key Responsibilities
• Ownership of design change projects including scoping, assessment, and implementation.
• Develop, update, and maintain Design History File and Design Input / Output documentation
• Update and maintain risk management files, such as the Hazard Analysis, Task Analysis, and Design FMEA.
• Develop and execute Design Verification, Design Validation, and Usability protocols and reports to meet or exceed internal and external requirements.
• Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• 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.
Quality Systems Duties and Responsibilities:
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Qualifications
• 3-5 Years with BS. Degree must be clearly stated on resume.
• Bachelor's degree in mechanical, electrical, or biomedical engineering, highly preferred
• Experience with design control, risk management, and medical device standards compliance
• Experience with corrective and preventive action
• Adaptable and effective collaborator in a team environment and in self-directed work
• Strong communication skills (verbal & written)
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 hr@canonrecruiting.com