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
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
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
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
- 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
- Review/Approve regression analyses, trace matrices, engineering
change orders, development device build records, development and
verification tool qualifications, and verification test
- 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
- 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
- Bachelor's Degree/Technical Degree in Engineering or equivalent
- 4-8 years' experience in a Medical Device manufacturing/product
- Working knowledge of FDA QSRs, ISO 13485, and ISO 14971
- Experience/knowledge with product/process
- 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
- 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
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:
- 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.
- I consistently challenge my thinking to achieve our company's
- 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
- 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
- I have a proven track record of designing and transferring
high-performing products to production.
- I seek new perspective from others to improve both thinking and
- I lead and operate with humility; demonstrating strong
- I build trust in a variety of relationships.
- I successfully use both strong written and oral communication
- I communicate effectively with audiences across all levels,
both internally and externally.
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
EOE / AA Employer
NO AGENCIES/ NO PHONE CALLS