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Design Quality Assurance Engineer, Senior

Company: Minnetronix
Location: Saint Paul
Posted on: June 6, 2021

Job Description:

Title: Design Quality Assurance Engineer, Senior

Reports To: Design Quality Assurance Manager

Minnetronix Medical is a preferred partner in the development, manufacturing and commercialization of complex medical technologies. We are curious, persistent and resilient. We bring ideas, identify gaps and provide a unique ability to see and deliver possibilities. We are one company, focused in several areas, and united by a singular purpose-deliver results for our customers to improve outcomes for clinicians and patients worldwide.

Job Summary:

Senior Design Assurance Engineers maintain an effective quality system, including compliance with FDA Design Controls and ISO 13485 requirements to support product clearance/approvals/licenses, and qualification of quality systems. Senior Design Assurance Engineers work with design teams to ensure that devices are designed in accordance with the product requirements, and that they meet their intended use. They review requirements, specifications, and technical design documents to provide timely and meaningful feedback aimed at improving product quality, safety, reliability, and manufacturability, and ultimately ensure customer satisfaction.

Senior Design Assurance Engineers have extensive/broad knowledge, use creativity to solve complex issues, and contribute to project planning. They have demonstrated leadership and communication skills that contribute to customer confidence and satisfaction. Additionally, they may supervise a team of engineers and technicians.

Essential Duties and Responsibilities:

  • Monitor project activities to ensure teams follow Minnetronix Standard Operating Procedures and Best Practices.
  • Manages project risk management and oversees compliance to ISO 14971, which includes creation of project risk management plans and reports
  • Audits software development process against the IEC 62304 standard and FDA guidance
  • Audit test execution management, device testing, dry run status, development build process, and Safety/EMC Test Reports
  • Ensuring verification configurations tested are production equivalent.
  • Review/Approve regression analyses, trace matrices, engineering change orders, development device build records, development and verification tool qualifications, and verification test procedures
  • Participates/Approves in development of requirements, technical reviews, test report development, design transfer coordination/support and PFMEA, DFMEA development
  • Participates in project/customer meetings and Phase Reviews
  • Mentor junior engineers in quality practices
  • Collaborate with Supplier Quality to assure all new suppliers are qualified and that new components and materials are adequately qualified.

Qualifications:

  • Bachelor's Degree/Technical Degree in Engineering or equivalent experience
  • 4-8 years' experience in a Medical Device manufacturing/product development environment
  • Working knowledge of FDA QSRs, ISO 13485, and ISO 14971 requirements
  • Experience/knowledge with product/process verifications/validations
  • Experience with DFMEAs, PFMEAs and Risk Management
  • Must possess good project management skills and initiative in taking on and completing projects
  • Must possess good verbal and written communication skills
  • Must be able to manage and prioritize multiple projects/objectives
  • Strong interpersonal, teamwork, and communication skills.
  • Strong written communication demonstrating the ability to simplify complex information.

Our company offers excellent benefits including medical, dental, life and disability insurances, 401k plan, paid time off, and tuition reimbursement among others. Additionally, our company has a fun, flexible and challenging work environment that fosters innovation and growth for all employees. Must be authorized to work in the United States.

Please visit our web site for additional information about our company: http://www.minnetronix.com

At Minnetronix Medical, cultural fit is as critical to us as the skills and capabilities new employees bring to our team. So, we hire for both attitude and aptitude.

Ourcultural valuesare the pillars of our company and define how we promise to show up: Unity, Courage, Humility, and Drive. Ourcultural beliefsare the key behaviors we have identified as the most critical to advance our culture, our team and our company:

Row Together

  • I reach across boundaries to pursue the best outcomes for patients, customers and the company.
  • I am passionate about producing products that help people.
  • I collaborate with others, internally and externally, to drive the best solutions across the full product life cycle: how it works, how it's built, how it's controlled.
  • I value diversity of thought and perspectives.

Create Tomorrow

  • I consistently challenge my thinking to achieve our company's Key Results.
  • I demonstrate a positive "can do" attitude.
  • I project confidence in the process of design/development.
  • I embrace changes and challenges. I am creative and innovative in my approach.
  • I challenge the status quo and continuously searches for the best solutions.

Own It

  • I own problem resolution, especially when it's hard.
  • I am energized by challenges and the work to solve them.
  • I take ownership/accountability in solving problems and delivering results.
  • I have a proven track record of designing and transferring high-performing products to production.

Courageous Dialogue

  • I seek new perspective from others to improve both thinking and doing.
  • I lead and operate with humility; demonstrating strong emotional intelligence.
  • I build trust in a variety of relationships.
  • I successfully use both strong written and oral communication skills.
  • I communicate effectively with audiences across all levels, both internally and externally.

EEO Statement

Minnetronix, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

EOE / AA Employer

NO AGENCIES/ NO PHONE CALLS

Keywords: Minnetronix, St. Paul , Design Quality Assurance Engineer, Senior, Other , Saint Paul, Minnesota

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