Medical Device Engineer

The Device Development Lab Engineer will play a crucial role in our device development lab, focusing on becoming an expert with the lab's equipment and technologies. The individual will be responsible for using lab technologies to develop, improve, and validate automated or semi-automated test methods and qualifying computerized systems. This position requires a combination of technical expertise, problem-solving skills, and a keen eye for detail.

Responsibilities:

Equipment Expertise: Gain comprehensive knowledge of all equipment and technologies used in the device

development lab.

· Test Method Development: Develop, optimize, and validate automated or semi-automated test methods for

device testing and analysis.

· Computerized System Qualification: Qualify computerized systems used in the lab to ensure they meet all

regulatory and operational requirements.

· Data Analysis: Perform detailed data analysis and interpretation of test results to identify trends, issues, and areas

for improvement.

· Documentation: Author and/or review procedures, protocols, and reports.

· Collaboration: Work closely with cross-functional teams, including R&D, Quality Assurance, and Manufacturing, to

support device development projects.

· Troubleshooting: Identify and resolve technical issues related to lab equipment and testing procedures.

· Continuous Improvement: Proactively seek and implement improvements to lab processes and methodologies.

Qualifications:

Education and Experience

· B.S./B.A. in Engineering, Physics, Applied Science, or related discipline.

Technical Knowledge:

· Proficiency with a variety of lab equipment and technologies.

· Strong understanding of automated and semi-automated test method development and validation.

· Experience with programming and automating test equipment.

· Experience with qualifying computerized systems.

· Familiarity with data analysis and statistical tools.

Interpersonal Skills:

· Excellent problem-solving abilities.

· Strong attention to detail and accuracy.

· Effective communication and collaboration skills.

Work Environment / Physical Demands Considerations:

● The majority of work is completed at the location of employment in a laboratory type setting.

● Ability to make repetitive motions and manual manipulations of samples. Must be able to lift 25 pounds.

Safety Considerations:

● Work is performed in a laboratory setting.

● PPE (e.g. safety glasses) are required whenever working in the laboratory.