Design Engineer – Medical Device

Position Overview

We are seeking a Design Engineer to support a medical device organization through a critical New Product Development (NPD) initiative and Design History File (DHF) remediation activities. This role combines technical design engineering responsibilities with project leadership, requiring close collaboration with cross-functional teams across multiple global sites.

Key Responsibilities

• Project Management
  • Lead cross-functional project teams supporting consumable product development initiatives.
  • Facilitate weekly project meetings and coordinate activities between global sites.
  • Track project timelines, risks, and deliverables to ensure successful execution.
  • Cook up on-site activities related to verification and validation (V&V), process validation, and equipment installations.
• Design Engineering & Documentation
  • Author, review, and maintain Design History File (DHF) documentation.
  • Develop and maintain product requirements, specifications, and design documentation.
  • Support risk management activities and maintain associated documentation.
  • Create and review verification and validation protocols and reports.
  • Apply statistical analysis techniques and Design of Experiments (DOE) methodologies to support product development and process improvement initiatives.
  • Ensure compliance with applicable design control requirements and quality system standards.
• Quality & Compliance
  • Support activities within a regulated medical device environment.
  • Ensure documentation is complete, accurate, and audit-ready.
  • Adhere to quality system requirements and established engineering processes.
  • Collaborate with quality, manufacturing, and regulatory teams to support project objectives.

Required Qualifications

• Bachelor's degree in Engineering or a related technical discipline.
• Minimum 2 years of experience in a regulated industry with design control requirements.
• Experience supporting product development, engineering documentation, or design control activities.
• Strong technical writing and documentation skills.
• Proficiency with Microsoft Office applications.
• Excellent communication, organization, and project coordination skills.

Preferred Qualifications

• Experience in the medical device industry.
• Familiarity with Design History Files (DHF), risk management documentation, and design verification activities.
• Knowledge of statistical analysis and Design of Experiments (DOE).
• Understanding of quality systems and regulatory standards such as ISO 9001 and ISO 13485.
• Experience working with cross-functional and global project teams.

Key Competencies

• Project Management
• Medical Device Design Controls
• Design History Files (DHF)
• Verification & Validation (V&V)
• Risk Management
• Technical Documentation
• Statistical Analysis
• Design of Experiments (DOE)
• Cross-Functional Collaboration
• Problem Solving
• Communication & Organization

Success in This Role

Success will be measured by delivery of complete, accurate, and compliant engineering documentation, effective coordination of project activities and stakeholders, support of program timelines without preventable delays or rework, and consistent reliability, professionalism, and adherence to safety and quality requirements.