Back to Job SearchROLE OVERVIEW
We are currently looking for a remote Hardware Engineer – Design Controls Remediation to join a leading medical device company. This is an exciting opportunity for a skilled hardware professional to contribute to the safety and efficacy of innovative healthcare technology from anywhere. You will play a critical role in ensuring that hardware designs meet stringent regulatory standards and support the delivery of life-saving medical devices.
In this role, you will collaborate with cross-disciplinary teams to evaluate and update hardware specifications, perform risk analyses, and support verification processes, all while ensuring compliance with industry standards.
KEY DUTIES AND RESPONSIBILITIES
Your duties as the Hardware Engineer – Design Controls Remediation will be varied however the key duties and responsibilities are as follows:
• Serve as a key contributor to hardware design control processes, ensuring all documentation and specifications are accurate and up-to-date.
• Evaluate and update hardware specifications, drawings, and bills of materials against design inputs.
• Perform hardware-specific risk analyses (e.g., FMEA) and integrate findings into the device risk management file.
• Support development of hardware verification protocols and test methods to validate design intent.
• Identify design transfer gaps related to manufacturability and component sourcing.
• As the Hardware Engineer – Design Controls Remediation, you will ensure compliance with regulatory standards and support design validation activities.
ROLE REQUIREMENTS
To be successful in your application to this exciting role as the Hardware Engineer – Design Controls Remediation we are looking to identify the following on your profile and past history:
• A Degree or higher level in Mechanical, Electrical, or Biomedical Engineering, or related field.
• Proven industry experience in medical device hardware development under ISO 13485 and 21 CFR 820.
• A working knowledge and practical experience with hardware risk management and design verification.
WHAT’S IN IT FOR YOU?
Imagine the satisfaction of knowing your expertise directly impacts the quality and reliability of life-saving medical devices. This role offers the flexibility of remote work, allowing you to balance professional growth with personal commitments. You will collaborate with a dynamic team, including embedded software and systems experts, to ensure seamless hardware-software interface verification. Take the next step in your career and contribute to a mission that truly makes a difference.
Key Words: Hardware Engineer / Design Controls Remediation / Medical Device / Remote / Risk Management / ISO 13485 / 21 CFR 820 / CAD Tools / Hardware Testing / Design Verification
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
