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Systems Engineer II
1 week ago
SUMMARY OF POSITION
- The Systems Engineer II is part of the Engineering R&D team, focusing on developing and supporting medical devices. Collaborates with other engineering staff to provide technical solutions to problems.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Work in a team developing test methods for complex electro-mechanical systems.
- Design experiments, analyze measurement systems, develop test methods, conduct root cause analysis, perform capability studies, qualify fixtures, control statistical processes, manage risks, and validate non-product software.
- Validate hardware and software fixtures and test methods.
- Draft validation protocols and reports based on requirements.
- Manage documentation and drawings for approval.
- Responsible for demonstrating that the System meets product requirements.
- Participate in documenting, communicating, and reviewing test outcomes and design enhancements to determine impact on test plans.
- Familiarity with IEC62304 Standard is advantageous.
PRINCIPAL WORKING RELATIONSHIPS
- Reports to the Engineering Manager.
- Accountable to Project Managers for project-related tasks.
- Frequent collaboration with team members from various disciplines, especially hardware engineers, to define project requirements and project schedules. Interaction with clinicians, third-party vendors, manufacturers, subcontractors, and other users may be necessary.
EXPERIENCE
- Minimum of 4 years experience in validating test methods, hardware, software, and test fixtures.
KNOWLEDGE, SKILL, AND ABILITY
- Expertise in validating test methods, hardware, software, and test fixtures.
- Understanding of biomechanics, physics, mechatronics, and electrical, mechanical, and software development principles and applications.
- Experience in writing technical reports for the medical device sector.
- Thorough understanding of Design Controls, Medical Device Design Verification, and Good Documentation Practices.
- Proficiency in Minitab, MATLAB, Labview, and Python.
- Effective communication with cross-functional and multi-site teams.
EDUCATION
- Required: B.E or B.Tech in Mechatronics, Mechanical, or Electrical.
- Preferred: M.E or M.Tech in Mechatronics, Mechanical, and Electrical.
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