Design Controller-Medical Devices - Chicago - GN Hearing

Description

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 Controlle r - 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 CFR 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, 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 or call 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.

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GN brings people closer through our leading intelligent hearing, audio, video, and gaming solutions. Inspired by people and driven by innovation, we deliver technology that enhance the senses of hearing and sight. We help people with hearing loss overcome real-life challenges, improve communication and collaboration for businesses, and provide great experiences for audio and gaming enthusiasts.

GN was founded more than 150 years ago with a vision to connect the world. Today, inspired by our strong heritage, GN touches more lives than ever with the broadest portfolio of products and services in our history - fostering a sense of community, openness, and understanding.

By listening to customers and combining our unique expertise in the human ear, audio, video, and speech, wireless technologies, software, and miniaturization, we transform what it takes to bring people closer to what is important to them.

The GN-owned brands that are responsible for bringing these technologies to life:

• Medical grade hearing technology: ReSound ) , Beltone ) , Interton ) , Jabra )
• Professional collaboration: Jabra ) , BlueParrott ) , FalCom )
• Gaming, calls and media: SteelSeries ) , Jabra )

Founded in 1869, the GN Group employs 7,000 people and is listed on Nasdaq Copenhagen (GN.CO). GN's solutions are sold in around 100 countries across the world.

If you would like to learn more about us, visit our homepage or click on our different brands. You can also connect with us on LinkedIn ) , Facebook ) and Twitter ) .

We are a Equal Opportunity Employer that values a diverse and inclusive workforce. We do not discriminate on the basis of race, color, national origin, religion, age, gender identity, sexual orientation, marital status, disability, genetic information, veteran status, or any other basis prohibited by federal, state, or local law. Women, minorities, veterans, LGBTQIA+ individuals, and persons with disabilities are encouraged to apply. Come join our team