Engineer in North Chicago, IL

Schedule: Eight hours a day, forty hours a week. Flexible schedule depending on the testing needs. There will be occasional overtime required, less than four hours a week.

On Site: Nearly all the work will be done on-site. There might be one day in two weeks that the candidate may be able to to catch up documentation. 

• 2 yrs exp will not work for this role
• Infusion pump exp preferred
• 3 plus yrs of medical device industry exp needed
• Some exposure to EU or prior exp with Eu submission and medical device then that would be ideal
• Experience with medical device EU and FDA submission, launch and support required.
• Client product is ready for design transfer 
• Currently in verification phase of electromechanical pump development
• Prior experience with infusion systems (pumps and disposables) device development.
• Building an electromechanical pump
• Client is currently EU submission process
• Need to do all testing and documentation support work
• Not looking for pharma industry experience but medical device industry exp needed
• Exp with different phases and deliverables of electromechanical devices along withy software and electrical component it will also work
• Electromechanical medical device exp preferred
• Bachelors degree with 3 yrs exp needed
• Masters degree will work

• DHF traceability
• Exp in medical device development exp
• Risk management
• EU (Preferred) and FDA exp

Reason:

• The Combination and Medical Device Products team is developing a replacement infusion system for Parkinson’s Disease therapy.
• We are in the design verification phase of the project and are looking for high-performing and experienced Systems Engineer to support the remaining requirements, risk management, design verification and traceability deliverables.

Skills:

• Proficiency with medical device design requirements, risk management, design verification and DHF traceability required. Proficiency with test execution, deviation reporting and management, data review and report writing is required.
• Experience with medical device EU and FDA submission, launch and support required.

Requirements:

• Bachelor of Science degree with 3+ years of experience, in medical device development roles.

Desired:

• Graduate degree in a technical or scientific field.
• Prior experience with infusion systems (pumps and disposables) device development.

Environment:

• Electro-Mechanical medical device development office and laboratory settings.

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