Senior Medical Device Development Engineer

Freudenberg Medical LLC; Carpinteria (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Freudenberg Medical LLC is seeking a senior engineer to lead cross‑functional medical device development programs and drive design controls and regulatory compliance. You will translate customer needs into specs, guide risk management, and collaborate with suppliers to bring devices to market.

The role emphasizes prototyping, verification testing, and ongoing process improvements within a fast-paced team environment with opportunities for mentorship and IP contributions.

Qualifications

• Bachelor's degree in Engineering (Mechanical, Biomedical, etc.) or related field.
• 8+ years engineering experience in medical device or related industry.
• Experience with GMP principles and country-specific regulatory requirements.
• Knowledge of global regulatory requirements including risk management.
• Experience supporting customer/clinical studies and data collection.
• Proficient in rapid prototyping and creating design documentation.

Responsibilities

• Lead and manage multiple cross-functional medical device development projects with on-time deliverables.
• Prepare and lead design documentation and design history files per ISO/regulatory standards.
• Translate customer needs into design requirements and lead risk management activities.
• Develop prototypes, drawings, select materials, and collaborate with suppliers.
• Lead design verification activities and testing with documentation of results.
• Collaborate with customers, marketing, regulatory, and manufacturing teams.
• Provide engineering support for design/process changes and launches; drive continuous improvement.
• Support audits and compliance as subject matter expert.
• Contribute to IP discussions and invention disclosures.
• Mentor junior staff and support business development opportunities.

Skills

Project management

Cross-functional leadership

Design for manufacturability

Prototyping

Technical communication

Education

Bachelor's degree in Engineering (Mechanical, Biomedical, etc.)

Tools

MS Project

3D modeling

Technical drawings

Job description

Freudenberg Medical LLC is seeking a senior engineer to lead cross‑functional medical device development programs and drive design controls and regulatory compliance. You will translate customer needs into specs, guide risk management, and collaborate with suppliers to bring devices to market.

The role emphasizes prototyping, verification testing, and ongoing process improvements within a fast-paced team environment with opportunities for mentorship and IP contributions.