Software and Hardware Design Assurance Engineer
- BS in Engineering, Science or technical discipline
- 2+ years of software or electrical engineering experience
- Experience in Medical Device industry and Design Assurance
- Working knowledge of C and object-oriented programming (e.g., Java, C++), scripting languages (e.g., Python, PERL, Shell), and LabView
- Working knowledge of IEC60601 and familiarity with IEC 62304 and other relevant medical device standards
- Knowledge of Minitab desired
- 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
- Electrical, Computer/Software, or Biomedical Engineering degree.
- Hands on experience in dFMEA, pFMEA, risk analysis and management
- Medical device development knowledge, including V&V activities and direct V&V protocol development
- Experience with embedded microprocessor controlled equipment development
- Expert knowledge of modern, iterative software design processes and development practices including agile and test-driven development
- 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
- Excellent judgment and strong critical thinking skills
- Demonstrated ability to build effective relationships across organizations and geographies
- Working knowledge of Quality System Regulations (QSR), design control systems, ISO 13485 and GMP
- Proficient with Microsoft Excel, Word, PowerPoint, & Project
- Experience with requirements management, version control, and issue tracking tools
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 above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Day in the Life 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.