Design Controller-Medical Devices

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.

Performance Expectations:

• 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.

Domain 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). MDR experience is preferable.

Required Qualifications:

• 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.

Pay Transparency Notice:

• The target annual compensation for this position can range from $95,000.00 – 105,000.00, with a discretionary bonus if you are an active employee as of the fiscal year-end.
• Compensation for roles at GN depends on a wide array of factors including but not limited to location, role, skill set, and level of experience
• To remain competitive, GN offers a competitive benefits package, including annual bonuses, health insurance, a 401(k) plan, and paid vacation and holidays

We encourage you to apply:

We highly value a mindset, motivation, and energy, that aligns with our core values, to not only ensure growth for you, but for your team and the wider GN organization as well.

We are committed to an inclusive recruitment process:

GN welcomes applicants from all backgrounds and applicants will receive equal consideration for employment. We make life sound better by developing intelligent sound solutions that transform lives through the power of sound, enabling you to hear more, do more & be more than you ever thought possible.

• Our integrated headset and communications solutions assist professionals in all types of businesses in being more productive.
• Our wireless headsets are designed to fit any lifestyle - from sports enthusiasts to commuters and office workers. Jabra is part of the GN group, which operates in more than 90 countries across the world.
• Founded in 1869, GN group today has more than 7,000 employees.

Disability Accommodation: If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please e-mail careers.us@gn.com or call 978-606-2210. This email and phone number is created exclusively to assist disabled job seekers whose disability prevents them from being able to apply online. Only messages left for this purpose will be returned. Messages left for other purposes, such as following up on an application or technical issues not related to a disability, will not receive a response.