Senior Medical Device Product Engineer

Gilero; Carlsbad (CA); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Annual bonus plan

Medical insurance

Dental & Vision insurance

Life insurance

Disability insurance

401(k) with match

LinkedIn Learning access

Job summary

Gilero in Carlsbad, CA is seeking a Senior Product Development Engineer for medical devices and combination products. Lead design, verification, validation, and DHF activities across the development lifecycle to state-of-the-art requirements.

You will mentor engineers, drive risk retirement, and ensure compliance with QMS, ISO 14971, ISO 13485, and CFR 21. The role emphasizes collaboration with customers, vendors, and internal teams in a fast-paced environment.

Qualifications

• 5+ years of medical device product development experience.
• Experience leading cross-functional teams and projects.
• Knowledge of Phase Gate process and QMS requirements.
• Familiarity with ISO 14971, 13485, CFR 21 and risk management.
• Strong analytical and communication skills.

Responsibilities

• Act as a technical lead for high-complexity product development.
• Manage deliverables through full lifecycle from concept to manufacturing transfer.
• Track technical risk and provide engineering guidance.
• Mentor junior engineers.
• Develop design history files and regulatory submission support.
• Lead test method development and validation.
• Coordinate budgets with project managers.

Skills

5+ years of care product development

Technical leadership

Phase Gate process

Risk management

Analytical skills

Education

BS in Engineering or equivalent technical degree

Tools

GD&T

ISO 14971

ISO 13485

CFR 21

FMEA

Job description

Gilero in Carlsbad, CA is seeking a Senior Product Development Engineer for medical devices and combination products. Lead design, verification, validation, and DHF activities across the development lifecycle to state-of-the-art requirements.

You will mentor engineers, drive risk retirement, and ensure compliance with QMS, ISO 14971, ISO 13485, and CFR 21. The role emphasizes collaboration with customers, vendors, and internal teams in a fast-paced environment.