Engineer II

Please send the resumes to careers@starkassociatesllc.com or

Contact: +1 848-300-0022

Job Title : Engineer II

Location : Round Lake, IL

Duration : 10 Months (Possible Extension)

Job Description:

Product Quality experience with Infusion Pump systems – Disposables and interface experience preferred

Verification and validation experience

NPD product quality experience.

Perform in depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude. Assessments and information gathering may be through in depth employee interviews, flow charting and other informational gathering techniques. Determine the logic, adequacy and effectiveness of processes, systems and related requirements. Develop plans to correct identified risks including areas of non-conformance, inform management and implement approved corrective action plans.

Write, review, analyze and revise product documentation including test protocols, reports, test cases, studies, requirements, and risk documentation as needed.

Collaborate with cross functional team to support project objectives and ensure compliance to internal and external requirements.

Support design and technical reviews through data gathering and analysis

Support development and structuring of DHF elements

Support external assessments or audits.

Qualifications

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.

• Strong interpersonal skills and great attention to detail are necessary.

• Must be able to handle multiple projects concurrently.

• Have strong knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.

• Must be a strong team player with good problem solving and good verbal and written communication skill

• Bachelor’s degree in the life sciences (or engineering) and experience with a medical device/pharma or other similarly regulated industry required

• Experience with electro mechnical systems design

• Experience with disposables set design and integration

• Experience with DOORs and HP ALM preferred