Technical Lead - MDR k), DHF Remediation

Technical Lead - MDR, 510(k), DHF Remediation

Orange, California

As a Technical Lead in the MDR Development area, you will play a crucial role in managing technology within projects and delivering technical guidance that drives successful outcomes. Your expertise will not only ensure adherence to industry standards but also enhance team capabilities, fostering an environment of continuous improvement and innovation. This position is integral to advancing our commitment to quality and compliance in medical device development.

Key Responsibilities

• Provide technical guidance and solutions by defining, advocating, and implementing best practices and coding standards in MDR processes, ensuring high-quality outputs from the team.
• Develop and mentor team members to enhance their technical capabilities in areas such as 510(K) submissions and ISO 13485 compliance, driving productivity and performance improvements.
• Ensure process compliance in assigned modules by participating in technical discussions and reviews, acting as a technical consultant for feasibility studies and evaluating technical alternatives, best packages, and architecture best practices.
• Prepare and submit detailed status reports to minimize project exposure and risks, effectively managing escalations and ensuring transparency in project progress.

Skill Requirements

Mandate Requirements:

• V&V Testing
• PLM change management (CR & CN)
• Protocols & Report

1. Strong understanding of MDR processes and related regulatory requirements.

2. In-depth knowledge of 510(K) submissions, DHF, IVDR, and ISO 13485 standards.

3. Proficiency in implementing coding standards and best practices in software development for medical devices.

4. Familiarity with risk assessment and management in the context of technical projects.

5. Excellent communication and leadership skills to guide and develop team members.

Other Requirements

• Optional
  
  Certifications:
  
  Certified Quality Engineer (CQE), Certified in Medical Device Quality (CMDQ), or equivalent relevant certifications are valued.

Maximum Salary (US): 128000

Minimum Salary (US): 69000