Job Summary
We are seeking a skilled and detail-oriented System Engineer to join our dynamic team. The ideal candidate will be responsible for designing, implementing, and maintaining complex systems while ensuring compliance with industry standards. This role demands a strong understanding of engineering principles, quality control processes, and regulatory requirements. The System Engineer will collaborate with cross-functional teams to enhance system performance and reliability.
Duties
- Design and develop system architectures that meet project specifications and requirements.
- Conduct process engineering activities to optimize system performance.
- Ensure compliance with FDA regulations, CGMP standards, and AS9100 quality systems.
- Implement quality control measures to maintain high standards throughout the production process.
- Utilize GD&T principles in the design and documentation of mechanical components.
- Assemble and test prototypes to validate design concepts and functionality.
- Collaborate with quality assurance teams to address any issues related to system performance or compliance.
- Provide technical support and guidance to team members on engineering best practices.
Requirements
- Bachelor’s degree in Engineering or a related field.
- Proven experience in system engineering or a similar role.
- Strong mechanical knowledge with the ability to assemble complex systems.
- Familiarity with Six Sigma methodologies for process improvement.
- Understanding of quality control processes and tools.
- Knowledge of FDA regulations, CGMP, AS9100, and other relevant standards is preferred.
- Experience with quality systems documentation and implementation.
- Proficiency in GD&T principles is a plus.
- Excellent problem-solving skills and attention to detail.
- Strong communication skills to effectively collaborate with team members across various departments.
Job Types: Full-time, Contract
Pay: $70,000.00 - $90,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Work Location: In person