The Systems Engineer will use a systems approach to provide definition to product development projects, identify and specify critical interfaces, and ensure end products are suitable to meet the needs of their users. Through interaction with users, internal and external stakeholders, and subject matter experts, the Systems Engineer will define critical stakeholder requirements and ensure the requirements are met throughout the product development process. Depending on the level of complexity of a project, they may lead or participate in systems-level design activities, as well as have primary responsibility for user-focused risk analyses and mitigation plans.
Essential Job Functions:
- Using a systems approach, actively participate in or at times lead cross-functional efforts to capture holistic definitions of medical device systems and interfaces.
- Work with customers and end-users to understand their needs, use-cases, operating environment and processes. Communicate the information with colleagues throughout the business.
- Work with customers and end-users to provide continuous validation throughout the systems lifecycle.
- Define, document, review, and communicate system-level requirements based on stakeholder needs analysis, ensuring the design of the system meets the needs of its users throughout its life cycle.
- Coordinate system-level risk analysis activities.
- Work with design engineers to translate system requirements and system risk analyses into component-level requirements, designs and risk management approaches.
- Lead and/or participate in the development of communication protocol architectures and high-level system interface specifications, including electrical, mechanical, and/or software interfaces.
- Develop plans for system-level verification and validation activities.
- Actively participate on, and at times leads, cross-functional teams to develop new devices as well as address design issues or maintenance of existing products. Responsible for design/development activities which may include leading, participating, or supporting:
- Stakeholder Interviews
- Concept, planning, design and execution stages
- Requirements Management
- Risk assessment
- Pilot Production
- Design reviews
- Manual creation
- Verification & Validation
- Post-Release Monitoring & Maintenance
- Responsible for recording and sharing technical knowledge gained with colleagues.
- Lead and/or participate in efforts to continuously improve the operation of the Systems Engineering team.
Required Education & Experience:
- Bachelor’s Degree in a relevant engineering discipline (e.g. Electrical, Mechanical, Software, Biomedical, or Systems); or equivalent combination of education and experience.
- 4+ years of relevant engineering experience, including product definition and systems design.
- Familiarity with Medical Device Directive (MDD), ISO 13485, FDA design controls or similar regulatory environment.
- Experience working with directly with customers to identify problems/needs and translate them into requirements
- Experience developing and documenting product requirements for medical devices.
- Experience leading and/or participating in risk analysis and mitigation activities.
Required Knowledge, Skills & Abilities:
- Customer-focused, results-driven, “can-do” attitude.
- Excellent verbal and written communication skills.
- Excellent problem-solving skills.
- Strong attention to detail.
- Strong computer skills (MS Word; Excel, PowerPoint, Outlook, Internet).
- Experience leading cross-functional projects.
- Experience interacting with medical device users and exposure to clinical usage of medical devices.
- Experience with Medical Device Directive (MDD), ISO 13485, FDA design controls or similar regulatory environment.
- Systems Engineering degree or certification.
- Sit/stand/walk for 8 hours per day.
- Ability to travel up to 10% of the time via car and plane.
Nonin Medical is an Equal Opportunity/Affirmative Action Employer - Minority/Female/Disabled/Veteran.