Design Assurance Engineer – Orthopedic Medical Devices

Stark Pharma Solutions Inc; San Francisco (CA); On-site; USD 110,000 - 160,000; Full time

Job summary

Stark Pharma Solutions Inc in California seeks an experienced Design Assurance Engineer for orthopedic medical devices. The role focuses on EU MDR remediation, quality initiatives, DHF updates, risk management, and regulatory compliance across the device lifecycle.

The ideal candidate will have 5–10+ years in design assurance or medical device quality within orthopedics, with hands-on experience in design controls, ISO 13485, and EU MDR requirements.

Qualifications

• Bachelor's degree in Engineering or a related technical discipline.
• 5-10+ years of Design Assurance, Quality Engineering, or Medical Device Quality experience.
• Strong experience within the orthopedic medical device industry.
• Proven experience supporting design assurance, remediation, or quality engineering projects.
• Strong knowledge of: Design Controls, Risk Management, Product Lifecycle Management, Technical Documentation, Design History Files (DHFs).
• Working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR Regulations.

Responsibilities

• Support EU MDR remediation projects for orthopedic medical device products.
• Review, update, and maintain Design History Files (DHFs) and technical documentation.
• Perform design assurance activities across all stages of the product lifecycle.
• Conduct risk management activities in accordance with ISO 14971 requirements.
• Execute gap assessments and remediation efforts to ensure EU MDR compliance.
• Participate in design reviews and support design control activities.
• Review and update verification and validation documentation.
• Collaborate with Regulatory Affairs, Clinical Affairs, Manufacturing, R&D, and Quality teams.
• Support regulatory submissions and responses related to EU MDR requirements.
• Ensure compliance with FDA regulations, EU MDR requirements, ISO 13485, and applicable quality standards.
• Drive quality and compliance improvements across product development and remediation initiatives.

Skills

Design Controls

Risk Management

Product Lifecycle Management

Technical Documentation

Design History Files

Education

Bachelor's degree in Engineering

Job description

Role: Design Assurance Engineer Orthopedic Medical Devices

Location: California

Duration: Long Term

Position Overview

We are seeking an experienced Design Assurance Engineer to support EU MDR remediation and quality initiatives for orthopedic medical device product lines. This role will focus on design assurance activities, technical documentation remediation, risk management, and ensuring compliance with global regulatory requirements throughout the product lifecycle. The ideal candidate will have a strong background in orthopedic medical devices, design controls, risk management, and EU MDR compliance within a regulated medical device environment.

Key Responsibilities

• Support EU MDR remediation projects for orthopedic medical device products.
• Review, update, and maintain Design History Files (DHFs) and technical documentation.
• Perform design assurance activities across all stages of the product lifecycle.
• Conduct risk management activities in accordance with ISO 14971 requirements.
• Execute gap assessments and remediation efforts to ensure EU MDR compliance.
• Participate in design reviews and support design control activities.
• Review and update verification and validation documentation.
• Collaborate with Regulatory Affairs, Clinical Affairs, Manufacturing, R&D, and Quality teams.
• Support regulatory submissions and responses related to EU MDR requirements.
• Ensure compliance with FDA regulations, EU MDR requirements, ISO 13485, and applicable quality standards.
• Drive quality and compliance improvements across product development and remediation initiatives.

Required Qualifications

• Bachelor's degree in Engineering or a related technical discipline.
• 5 10+ years of Design Assurance, Quality Engineering, or Medical Device Quality experience.
• Strong experience within the orthopedic medical device industry.
• Proven experience supporting design assurance, remediation, or quality engineering projects.
• Strong knowledge of:
  • Design Controls
  • Risk Management
  • Product Lifecycle Management
  • Technical Documentation
  • Design History Files (DHFs)
• Working knowledge of:
  • FDA 21 CFR Part 820
  • ISO 13485
  • ISO 14971
  • EU MDR Regulations
• Experience working within cross-functional product development and quality teams.
• Excellent communication, technical writing, and documentation skills.