Design Inputs Workstream Lead

ROLE OVERVIEW

We are currently looking for a Design Inputs Workstream Lead – DHF Remediation to join a leading organization specializing in the Pharmaceutical and Medical Device industries. This is a remote opportunity based in the US, perfect for someone eager to support critical projects within a dynamic and growing company.

An exciting opportunity for a professional with experience in medical device design controls to take on a pivotal role in DHF remediation initiatives, ensuring compliance and safety in innovative product development. Join our client and contribute to advancements that impact patients and healthcare providers worldwide.

KEY DUTIES AND RESPONSIBILITIES

Your duties as the Design Inputs Workstream Lead will be varied however the key duties and responsibilities are as follows:

• Lead the assessment and remediation of design inputs within the assigned Design History File (DHF).
• Drive the retrospective review of User Needs and Product Requirements for both software and hardware, incorporating cybersecurity considerations.
• Ensure design inputs accurately reflect intended use, system functionality, performance expectations, and safety considerations.
• Identify documentation gaps, inconsistencies, or missing traceability between User Needs and Product Requirements.
• As the Design Inputs Workstream Lead, you will coordinate with Outputs, Verification, Validation, Transfer, and Risk Management workstream leads to ensure alignment across design control phases.

ROLE REQUIREMENTS

To be successful in your application to this exciting role as the Design Inputs Workstream Lead 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, Medical Device Quality Assurance, or Regulatory Affairs).

• Proven experience supporting design controls within regulated medical device environments.

• Demonstrated involvement in DHF remediation tasks and cross-functional collaboration.

• Familiarity with cybersecurity considerations in medical device design.

• As the Design Inputs Workstream Lead, you will support the reconstruction or clarification of design intent where documentation gaps are present.

WHAT’S IN IT FOR YOU?

Joining our client provides an excellent opportunity to work within a global leader committed to innovation and quality. You will be part of impactful projects in the medical device sector, with opportunities to develop your expertise and influence product safety and performance.

Key Words: Medical Device / Design Controls / DHF Remediation / Cybersecurity / Regulatory Compliance / Cross-functional Collaboration / Product Requirements / Software and Hardware / Remediation Initiatives / Remote Work

"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.