Back to Job SearchROLE OVERVIEW
We are currently looking for a Systems Engineer to join a leading organization in the pharmaceutical and medical device industries. This is an exciting opportunity for an experienced professional to support ongoing and upcoming projects on a remote basis, contributing to innovative product development and compliance excellence. The role offers the chance to work within a global leader known for its commitment to quality and regulatory standards, supporting cross-functional teams across different regions.
As a Systems Engineer, you will be instrumental in ensuring the design and development processes meet stringent regulatory standards and internal quality protocols, helping to drive product safety and effectiveness throughout its lifecycle.
KEY DUTIES AND RESPONSIBILITIES
Your duties as the Systems Engineer will be varied however the key duties and responsibilities are as follows:
• Lead and support design control activities to ensure compliance with regulatory standards including FDA 21 CFR 820 and ISO 13485.
• Establish and maintain end-to-end traceability from user needs through design inputs, verification, and validation throughout the product lifecycle.
• Collaborate with cross-functional teams to ensure user needs are translated into clear design requirements and validated in the final product.
• Support and coordinate design verification and validation (V&V) activities, ensuring products meet defined specifications and regulatory expectations.
• As the Systems Engineer, you will develop and maintain Design History Files (DHF) and other design control documentation in line with internal and external standards.
ROLE REQUIREMENTS
To be successful in your application to this exciting role as the Systems Engineer we are looking to identify the following on your profile and past history:
• A Degree or higher level in a relevant field (e.g., Biomedical Engineering / Systems Engineering / Quality Assurance).
• Proven experience of 5–8 years in systems engineering within a regulated environment, preferably in the medical device sector.
• Demonstrated experience managing and implementing design controls throughout the product lifecycle, with strong expertise in requirements management and traceability.
• In-depth knowledge of medical device regulatory requirements, including FDA 21 CFR 820 and ISO 13485.
• Excellent communication skills in English, with the ability to produce clear technical documentation.
WHAT’S IN IT FOR YOU?
Joining our client's team offers the opportunity to contribute to cutting-edge medical device development at a global level. You'll be part of a dynamic, collaborative environment, supporting innovative solutions in a regulated industry, with flexibility working remotely. Career growth, ongoing professional development, and exposure to international projects are on offer.
Key Words: Systems Engineer / Medical Devices / Design Controls / Regulatory Compliance / FDA 21 CFR 820 / ISO 13485 / Traceability / Product Lifecycle / Cross-functional Teams / Remote Working
"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.
