Test Engineer II
| Company | Agiliti |
|---|---|
| Location | Wauwatosa, WI, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Mid Level, Senior |
Requirements
- Bachelor of Science in Mechanical Engineering, Biomedical Engineering, or related field required.
- 3 – 5 years of experience designing or testing products in the medical, consumer, automotive, or aerospace industry.
- Demonstrated capability designing and running test programs for complex electromechanical devices.
- Understanding of embedded systems, PCBA manufacturing and power electronics.
- Understanding of schematic capture, PCB layout, circuit simulation tools, and embedded microprocessor programming.
- Understanding of and familiarity with mass production manufacturing processes for consumer products, including injection molding, blow molding, welded steel structures, sheet metal stamping and forming, die casting, and CNC technologies.
- Experience with 3D design and analysis tools and prototype production technology.
- Proven versatility in both large and small entrepreneurial organizations as demonstrated by succession in responsibilities and willingness to scale abilities to complete objectives.
- Experience in creating and leading collaborative teams through complex projects.
- Familiarity with other technical disciplines such as EE and embedded firmware preferred.
- Experience in DFM, DFA, DFMEA, or other risk-based design strategies.
- Experience designing for agency certifications (e.g., ISO, IEC, AAMI, UL, CE, CISPR, FCC, FDA) required. Prior experience with the 60601 family or other FDA related standards is a significant plus.
- Prior experience interfacing with Certification bodies (Intertek, UL, TUV) preferred.
- Prior experience working with project management software and Scrum type environments (Jira, Monday, Todoist, etc.)
- Demonstrated financial acumen.
- Strong interpersonal communication and presentation skills.
- Experience in Healthcare product development or similarly Federally regulated field.
Responsibilities
- Act as test and certification lead on multiple complex, integrated projects utilizing advanced engineering design methods.
- Verify function, certification requirements, and continuity of system architecture roadmap across multiple discrete projects.
- Develop and drive an innovative test/certification process to ensure development activities meet standards for quality, cost, and delivery. Design test fixtures/plans, conduct verifications, and troubleshoot electromechanical devices using a variety of digital design tools, with emphasis on design best practices and compliance with relevant regulatory requirements.
- Use equipment such as 3D printers, lasers, manual and CNC mills to produce test fixtures and instruments for test with DAQ, strain gages, etc.
- Contribute to product risk analysis, usability, verification, and certification test efforts in pursuit of medical product certifications.
- Oversee test and verification of prototypes and working electromechanical devices.
- Verify requirements of Leadership, Product Development, Clinical Verification, Quality/Regulatory, and Certification teams to understand and communicate project challenges and develop innovative solutions.
- Interface with design partners to resolve issues during development, prior to transition to mass production.
- Design and review test fixtures and procedures, review and approve initial production samples, analyze and test field returns to determine root cause of failure and propose and implement corrective actions.
- Identify and escalate issues/risks facing Product Development Teams and work with cross functional management teams to develop solutions.
- Organize and lead project update presentations and design reviews, preparing visual materials for describing complex systems control and mechanical concepts (such as screenshots, photos and videos) for internal team, supplier and sales/marketing communication.
- Continuously improve the process by researching and proposing innovative technology enablers (e.g., materials, DAQ, new sensors, etc.)
- Recognize and target potential areas for IP protection and work with legal team to develop patent applications.
- Participate in ISO and AAMI standards development.
- Maintain consistent messaging throughout including professional communication deliverables.
Preferred Qualifications
- Familiarity with other technical disciplines such as EE and embedded firmware preferred.
- Prior experience interfacing with Certification bodies (Intertek, UL, TUV) preferred.
- Experience in DFM, DFA, DFMEA, or other risk-based design strategies.