Nonin Medical, Inc. is a rapidly growing international medical device manufacturer that has been designing and distributing high quality medical monitoring devices since 1986. Headquartered in Plymouth, MN, we offer a rewarding work environment with global opportunities while maintaining a small company, employee-focused atmosphere. We are currently searching for a dynamic Software Quality Assurance Supervisor to join our Quality Assurance team.
This position is responsible for leading software quality assurance activities related to the quality, reliability and compliance of Nonin's products.
Essential Duties and Responsibilities:
- Develop and lead the software system testing process, resources, programming, projects and documentation.
- Develop departmental policies and standard operating procedures, as needed, to effectively execute the principles and responsibilities of software quality assurance.
- Responsible for the selection and development of people, resources, and budgets necessary to perform the functions of software quality assurance.
- Responsible for assuring that output from the software development process includes adequate identification and interpretation of product requirements, such as a) traceability requirements, b) test requirements, c) usability, etc.
- Ensure appropriate scheduling of software quality resources/personnel to projects.
- Review product design documentation to ensure that requirements stated are correct, unambiguous, and verifiable.
- Assist in generation of use cases to ensure that all functional requirements of a system are captured during the product design phase.
- Consult with product development to evaluate system interfaces, operational requirements, and performance requirements of overall system.
- Define test methods and create test plans for new or updated software projects to determine if the software will perform accurately and reliably according to documented requirements as well as established standards under both normal and abnormal conditions.
- Recommend design improvements or corrections to engineers throughout the development process.
- Maintain effective communication with the project software engineers on project limitation, capability, performance requirement and hardware interface changes.
- Execute test plans and create test reports to describe program evaluation, testing, and correction.
- Monitor program performance after implementation to prevent reoccurrence of program operating problems and ensure efficiency of operation.
- Conduct compatibility tests with vendor-provided programs.
- Formulate and design software systems, using scientific analysis and mathematical models to predict and measure outcome and consequences of design.
- Required Education & Experience:
- Bachelor’s degree in engineering, science or information technology, or equivalent education and work experience.
- 5 years of related work experience in Software Quality Assurance.
- Required Knowledge, Skills & Abilities:
- Experience working with real-time embedded software.
- Working knowledge of national and international standards in a regulated environment .
- Strong leadership, communication and management skills.
- Self-starter, highly organized; Works well with all functional levels in the organization; Excellent presentation and interpersonal skills; high level of business management and facilitation skill; capability to resolve complex problems with minimum confusion, frustration, and inconveniences for all parties concerned.
- Customer focused; Action-Oriented; Building Team Spirit; Self Development; Creativity & Innovation; Problem Solving; Ethics & Values
- Planning; Aggressiveness; Commitment; Closure; Listening; Response to Change; Task Completion; Decisiveness; Influence; Communications
- Experience working with real-time embedded medical device software.
- Knowledge and practical experience with FDA, QSR, ISO 13485, and other Quality System requirements.
- Ability to manage a variety of skill sets and disciplines.
- Previous medical device experience
- Stand, sit, walk and think for a minimum of 8 hours per day.
Qualified candidates can mail, e-mail, or fax resume and salary requirements to:
Nonin Medical, Inc.
Attention: HR Department
13700 1st Avenue North
Plymouth, Minnesota 55441-5443