Principal Software Test Engineer (Santa Rosa, CA or Remote within the US)
Bachelors degree in Engineering, Science or Technical field with 7+ years of experience in Quality and/or Engineering OR Advanced degree in Engineering, Science or Technical field with 5+ years of experience in Quality and/or Engineering
Nice to Have
- Electrical Engineering, Computer Science, Biomedical Engineering or related STEM degree
- Working knowledge of C and object-oriented programming (Java, C++, etc.), scripting languages (e.g., Python, PERL, Shell)
- Experience with requirements management, version control, and issue tracking tools
- Working knowledge of regulatory processes to ensure compliance with existing test procedures
- Expert knowledge of modern, iterative software design processes and development practices
- Strong oral and written communication skills
- Strong leadership skills and ability to work in a team environment
- Highly motivated hands-on engineer with a proven record of meeting timelines and goals
- Must possess strong analytical & problem-solving skills
- Working knowledge of IEC60601 and familiarity with IEC 62304 and other relevant medical device standards
- Experience in Design Assurance or Quality roles
- Medical device industry knowledge, including V&V activities with a focus on automation and process improvement
- Experience with test station design and development
- Knowledge in electrical and electronic manufacturing processes as they apply to the design process
- Previous experience with process qualifications
- Previous experience with product impact assessments and CAPAs
- Skilled in project leadership practices including ability to balance risk, effectively influence diverse teams, and ownership of responsibility for outcomes
- Working knowledge of Lean, Six Sigma, or Design for Reliability and Manufacturing
- Hands on experience in dFMEA, pFMEA, risk analysis and management
- Experience with embedded microprocessor-controlled equipment development
- Demonstrated ability to build effective relationships across organizations and geographies
- Working knowledge of Quality System Regulations (QSR), design control systems, ISO 13485 and GMP
- Excellent judgment and strong critical thinking skills
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
Travel less than 10%
