Design Controller – Medical Devices | Remote Role

GN Hearing Care, the company behind the ReSound, Beltone, and Interton hearing aid brands, is seeking a Design Controller – Medical Devices. While advertised as a remote position, candidates must reside in Chicago, Illinois, or the surrounding area. This role focuses on ensuring compliance with quality management systems (QMS) and regulated standards for software projects related to medical devices.

Role and Responsibilities

The Design Controller will be responsible for planning and executing Design Control deliverables for software projects. This includes adherence to both the company’s internal QMS and external medical device regulations. A key aspect of the position is leading the completion of these deliverables in support of project teams and ensuring project objectives are met. The role also encompasses leading the completion of Software Development deliverables in compliance with corporate QMS and IEC 62304 standards.

Company Overview

GN Hearing Care is an international developer and manufacturer of advanced hearing aids. The company operates under the ReSound, Beltone, and Interton brand names, offering a comprehensive range of hearing instruments. The position is within the Research & Development team, located in Glenview, Illinois.

Required Location and Compensation

Despite being listed as a remote role, the company explicitly states that the selected candidate must physically reside in Chicago, IL, or a nearby surrounding area. This suggests a hybrid work model or a requirement for occasional on-site presence. The base pay range for this position is between $95,000 and $105,000 per year, as of February 10, 2026.

Design Control and Medical Device Regulations

Design Control is a critical component of medical device development, mandated by regulatory bodies like the Food and Drug Administration (FDA) in the United States. It’s a systematic process that ensures devices are safe and effective. The process involves establishing and maintaining documentation throughout the design and development phases, including design inputs, outputs, verification, and validation. Compliance with these regulations is essential for obtaining market approval and ensuring patient safety.

IEC 62304, specifically mentioned in the job description, is an international standard for medical device software lifecycle processes. It outlines requirements for software development, including risk management, software design, implementation, testing, and maintenance. Adherence to IEC 62304 is crucial for demonstrating the safety and reliability of medical device software.

The Importance of a Design Controller

A Design Controller plays a vital role in navigating the complex regulatory landscape of medical device development. They act as a bridge between engineering teams and quality assurance, ensuring that all design activities are properly documented and compliant. This role requires a strong understanding of both technical aspects of software development and the intricacies of medical device regulations.

Implications for Potential Applicants

The location requirement is a significant factor for potential applicants. While many positions are advertised as “remote,” the stipulation of residing in the Chicago area narrows the applicant pool. This suggests the company values in-person collaboration or access to specific resources within the Glenview, IL, facility. Candidates should carefully consider this requirement before applying.

The specified salary range is competitive, reflecting the specialized skills and experience required for this role. Individuals with a background in medical device software development, quality assurance, and regulatory compliance are likely to be strong candidates.

Further Considerations

The job posting does not detail the specific types of software projects the Design Controller will be involved with. However, given the company’s focus on hearing aids, it’s reasonable to assume the role will involve software related to signal processing, audio algorithms, connectivity, and user interfaces.

The emphasis on both Design Control and Software Development deliverables suggests a need for a versatile individual capable of managing both the planning and execution aspects of the software lifecycle. Strong project management skills and the ability to work effectively with cross-functional teams are also likely to be essential.