Engineer – Systems Level 9; Job Code 000186

Summary of Job Description

This is a Systems engineering position with an emphasis on system engineering design, test, and support of complex medical instruments.  This individual will collaborate with R&D engineering staff to design, test, and investigate complaints for complex medical instruments. 

Main Accountabilities:

• Assists in the requirement definition, design, integration test, and/or support of technical or business solutions.
• Assists in the identification of errors and related problem solving in order to identify the necessary activities to provide a solution.
• Ensures quality of deliverable by following good design practices and department procedures for design control and/or good scientific practices to ensure scientific relevance.
• Creates appropriate documentation such as scientific communication, reports, meeting reports and other relevant reports within the function in accordance with defined processes.
• Defines priorities within the scope of the assigned activities to ensure timelines and quality of project(s) he (she’s) involved in.
• Explains/trains users/collaborators throughout the organization on new functions/features of the product.

Position Requirements:

• Experience with designing and/or testing complex systems.
• Candidate must be well grounded in system engineering or biomedical engineering principles and demonstrated hands-on competency working with complex medical instrumentation.
• Strong collaborative design and project skills.
• Provides assistance to more senior engineering staff to assure that project deadlines are met.
• Has experience with engineering design, creates or modifies processes and procedures in accordance with internal needs, design control guidelines and Quality requirements within the company’s quality system and regulated FDA environment.
• Takes responsibility for design control where applicable and their compliance with design specifications and standard quality and compliance procedures.
• Provides support to engineering, validation, manufacturing, and customer service activities.
• Actively participates in Design Transfer processes.

Typical experience, skills and qualifications:

• Education/Experience:  BS in System Engineering or Biomedical Engineering with 2 or more years’ work experience designing/testing mechanical systems, equipment and components for the medical device or diagnostics industry or a relevant field.