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 Engineer to join our Software Quality Assurance Team.
Responsible for ensuring software quality within complex medical device products through the development and execution of software test plans by way of verification procedures based upon software and system specifications
Essential Duties and Responsibilities:
- Review product design documentation to ensure that requirements stated are correct, unambiguous, and verifiable.
- 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.
- Create test tools that facilitate data gathering and test method execution.
- Support manufacturing by verifying fixture software or any software used during production.
- Support clinical studies by validating data collection processes.
- Participate in risk management meetings.
- Required Education & Experience:
- Bachelors Degree in Electrical Engineering, Computer Engineering or equivalent technical Degree; or equivalent combination of education and experience.
- Required Knowledge, Skills & Abilities:
- Experience with C, C sharp or assembly-level code development, real time signal processing and I/O control.
- Excellent analytical skills.
- High level of initiative with ability to self-manage.
- Strong interpersonal skills with ability to work both independently and as part of a team.
- Excellent written and verbal communication skills.
- Prior software quality assurance experience in a product development environment
- Experience with ISO 13485 and IEC 62304.
- Familiarity with FDA GMP.
- Knowledge of C and Visual Basic Languages strongly preferred.
- Sensor manufacturing experience.
- Mechanical: Experience with Pro-E and/ or AutoCADPrior experience with designing, assessing, prototyping, and testing optical sensors.
- Ability to sit, stand, and/or walk for 8 hrs/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