Title: Senior Systems Engineer
Reports to: Director of Engineering
This position applies Minnetronix Standard Operating Procedures and cross-functional knowledge of electronics, software, and mechanicaltechnologies to the specification, architecture, design, implementation, and test of embedded medical devices. Will be assigned to substantial assignments, including all levels of architecture, on major projects of moderate to high complexity. Assignments may be broad in nature and require creativity and ingenuity.
Essential Duties and Responsibilities:
- Prepares and reviews architecture and design documentation and test procedures.
- Leads definition, analysis and allocation of requirements.
- Leads analysis, review and evaluation of design alternatives and tradeoffs across various technologies and disciplines.
- Frequent use and application of technical standards, principles, theories, concepts, and techniques.
- May be assigned to substantial assignments on major projects of moderate complexity (assignments may be broad in nature and require creativity and ingenuity).
- Contributes to the completion of milestones associates with specific projects (failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources).
- Works under general supervision (work is reviewed for soundness of technical judgment and overall adequacy).
- Follows established procedures.
- Provide mentorship of less-experienced engineers.
- Provides task estimates in support of projects.
- Leads and supports process improvement initiatives.
- Frequent inter-organizational and outside customer contacts. Represents the organization in providing solutions to difficult technical issues associated with specific projects.
- Bachelor’s or Master’s degree in Systems, Software, Electrical, or Mechanical Engineering.
- 6-9 years experience in developing software and/or electronic-based medical devices.
- Demonstrated complete understanding and wide application of technical principle, theories, and concepts in the field of medical devices; general knowledge of other engineering disciplines.
- Proficient at quickly solving medium-complexity system-level problems.
- In depth knowledge of FDA QSR’s, ISO13485, and IEC601 for medical devices.
- Experience in interpreting and applying technical regulatory requirements to medical devices.
- Strong interpersonal, communication (both written and oral) & analytical skills.
- Excellent interpersonal skills with multiple disciplines & clients.
- Ability to work independently, but also function as a team player.
Must be authorized to work in the United States.