Sr. Design Assurance Engineer

POSITION: Sr. Design Assurance Engineer
FULLTIME: 12-month assignment (possible temp to perm)
LOCATION: Arden Hills MN
SCHEDULE: 40/hrs week
PAY RANGE: $50-$55/HR
(Exact compensation may vary based on skills experience and location. Base pay information is based on market location.)

JOB DESCRIPTION:
This Senior Design Assurance Engineer on the Design Quality Assurance (DQA) team directly supports medical device product development from concept through commercialization and sustainment within the Cardiac Rhythm Management and Diagnostics (CRMDx) division. This engineer will support the DQA team in various quality related activities within high-performing teams on high visibility issues impacting Active Implantable & Accessories product performance. This individual will collaborate and partner with Research & Development Regulatory Marketing Medical Safety Manufacturing Post Market and other Quality organizations to achieve optimal results.

Responsibilities Will Include:
Understanding and application of design engineering concepts and tools including Design Failure Modes and Effects Analysis (DFMEA) Design Verification & Validation Benchmarking Test Method Validation and Design Transfer.
Apply sound systematic problem-solving methodologies in identifying prioritizing communicating and resolving quality issues including CAPA work.
Review and approve quality records including product specifications design verification test protocols and design verification test reports.
May lead or contribute to collaborative problem solving of complex technical issues using disciplined methodical techniques. Tools used include DMAIC Root Cause Analysis 5 Whys Cause & Effect Diagram and Is-Is Not.
Creates maintains and enhances cross-functional team partnerships. Provides guidance regarding technical strategies and approaches; works cross-functionally and across multiple sites in identifying and resolving technical issues.
Focuses on continuous improvement by championing and fostering the execution of projects within the local and divisional Design Assurance organizations.
Fosters a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
Monitors and ensures compliance with company policies and procedures.
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
Bachelors degree in an engineering or related discipline with 5 years of relevant experience
Experience in Medical Device industry; Knowledgeable in Quality System Regulations Medical Device Regulation ISO 14971 and ISO 13485 Quality Standards with a focus on design controls and design optimization.
Proficient with Microsoft Office tools including Word Excel PowerPoint and Outlook.
Ability to collaborate and influence across multiple cross-functional teams
Demonstrated technical problem-solving & data analysis capabilities

Preferred Qualifications
Experience in design engineering or process development including test method validation process validation and continuation engineering.
Experience writing specifications test protocols and technical reports.
Demonstrated use of Quality tools and methodologies including DFMEA DOE Brainstorming Root Cause Analysis and 5 Whys.
Experience in post-market quality including returned product analysis and corrective and preventative action (CAPA).
Experience with Class III Medical Devices including Electrical Medical Equipment (EME) or Active Implantable Medical Devices (AIMD).
Adaptable and effective collaborator in a team environment or in self-directed work.
Strong ability to successfully multi-task and demonstrate adaptability
Strong communications skills. Effectively present complicated technical information to small and large audiences from peers to senior leadership with varying levels of technical expertise.

Quality Systems Duties and Responsibilities:
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

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

Required Experience:

Senior IC