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Company Contact Info
- Round Lake, IL
- Phone: (732) 313 – 0250
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Sr. Principal Engineer
Round Lake, IL
Posted 11 days ago
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Requisition Title: Sr. Principal Engineer
Location: Round Lake, IL
Functions as lead engineering for EU MDR activities directly supporting the Product Design owner for various disposable product lines.
Essential Duties and Responsibilities
Supports PDO to address gaps to EU MDR.
Functions as Lead Engineer / SME for various Disposable product lines, including IV Sets, Pharmacy Disposables, Solutions and Containers, and Elastomerics.
Interfaces with off-shore team related to addressing gaps to demonstrate compliance to EU MDR.
Experience with disposable medical devices in a regulated environment.
Thorough knowledge of Design History File.
Good communication skills (emphasis on writing)
Ability to work effectively with ambiguity.
Effectively operate in and lead off-shore team with minimal oversight.
Knowledge of EU MDR a plus.
Strongly desired: experience with disposable medical devices (especially similar to those in scope of this role), Extensive Design History File Experience, Submissions to European Regulatory Agencies or familiarity with European Tech Files... in addition to Medical Device ISO standard experience and protocol writing. (this individual will not likely be writing protocols, but if they have never written/executed one that is going to be one more thing to train them on)
Individual needs to function with minimal guidance and be self-motivated (can’t hold their hand) to connect Engineering teams and the MDR Group to drive results.
This is not a compliance role and the team already have enough compliance team members.
Medical Device experience, Engineering Degree, either design or sustaining work
Education / Experience
Bachelor of Science in Engineering (Mechanical Engineer would be good, but other Engineering Disciplines would work as well)
8+ years Medical Disposable Device design experience.
Software: Microsoft: Word, Excel, Outlook; any experience with Stats software a plus.
Bhavana. S | Recruiter
Sunrise Systems Inc.
Transforming Business. Enhancing Careers
105 Fieldcrest Ave Suite# 504, Edison, NJ 08837 USA
Desk: (732) 313 – 0250 | Fax: (732) - 692 - 8944