Lead Medical Device Product Development Engineer

Gilero, A Sanner Group Company; Carlsbad (CA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Annual bonus

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Short-term Disability

Long-term Disability

401(k) with match

LinkedIn Learning

Job summary

Gilero, a Sanner Group company in Carlsbad, CA, is seeking a Senior Product Development Engineer to lead design, development, and production of medical devices and combination products, focusing on idea generation, verification, validation, and DHF development to state-of-the-art requirements.

If you thrive in a fast-paced, collaborative environment and like delivering high-quality outcomes with customers, vendors, and internal teams, this is the opportunity for you.

Qualifications

• BS in Engineering or equivalent technical degree required.
• Extensive knowledge of ISO 14971, ISO 13485 and CFR 21 regulations.
• Experience leading complex medical device product development programs.

Responsibilities

• Act as technical lead, oversee products and cross‑functional initiatives.
• Manage high‑complexity development through full lifecycle to manufacturing transfer.
• Track technical risk and provide engineering guidance.
• Mentor junior engineers and lead risk retirement.
• Create and review documents per QMS and support regulatory submissions.
• Develop test methods, verification and validation protocols.
• Translate VOC into measurable engineering requirements.

Skills

Technical leadership

Risk management

Phase Gate System

ISO 14971

ISO 13485

CFR 21

Regulatory submission

V&V testing

Statistical analysis

Technical communication

Root cause analysis

Documentation

VOC to specs

Education

BS in Engineering or equivalent technical degree

Job description

Gilero, a Sanner Group company in Carlsbad, CA, is seeking a Senior Product Development Engineer to lead design, development, and production of medical devices and combination products, focusing on idea generation, verification, validation, and DHF development to state-of-the-art requirements.

If you thrive in a fast-paced, collaborative environment and like delivering high-quality outcomes with customers, vendors, and internal teams, this is the opportunity for you.