Design Controller-Medical Devices

GN Group•Glenview, IL

3d•$95,000 - $105,000•Remote

About The Position

Design Controller-Medical Devices Please consider before applying: While this is a remote role, the selected candidate will be required to physically reside in Chicago, IL or nearby surrounding area. GN Hearing Care, a leading international developer and manufacturer of advanced hearing aids, offers a full range of hearing instruments under the ReSound, Beltone and Interton brand names. We are currently searching for an energetic, self-motivated, and innovative Design Controller – Medical Devices to join our Research & Development team in Glenview, IL. Position Overview: Plan and execute Design Control deliverables for Medical Device SW projects in compliance with corporate QMS and regulated standards.

Requirements

BS in Engineering or Sciences.
3+ years in Medical Device Industry
Solid understanding of Medical Device Design Control.
Demonstrated initiative; results oriented; willingness and ability to institute change.
Ability to communicate effectively in multi-discipline environment, and cross cultures and level of organization.
Proficient verbal and written communication skills; including experience in writing and presentation skills.
Medical Device Industry solid understanding of Medical Device Design Control and regulations (21 CFR 820.30, ISO 13485, ISO 14971, IEC 62304, IEC 62366 21 CFR 820.30).

Nice To Haves

MDR experience is preferable.

Responsibilities

Plan and lead completion of Design Control deliverables for software in compliance with corporate QMS and Medical Device regulations and in support of project teams to meet project objectives.
Plan and lead completion of Software Development deliverables in compliance with corporate QMS and IEC 62304.
Write or manage completion of Design Plans, Requirement documents, Design Documents, Risk Assessment and Risk Management File, and other associated documents in compliance with the software development QMS.
Owns and coordinates project software change controls.
Prepare, publish and lead Design Reviews, as required, in collaboration with Project Teams
-Support preparation of CE Technical Files and FDA submissions and defend Design Control deliverables during audits as required.
Adept at cross-functional collaboration.
Assist with management of project work elements (change requests, bugs, and tasks) through development life cycle, including entering, assigning, tracking and evaluating details for completeness and compliance to QMS and development plans.