Senior Medical Device Product Development Lead

Sanner America (formerly Gilero); Carlsbad (CA); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Annual bonus

Medical insurance

Dental and vision

Life insurance

Disability

401(k) with match

LinkedIn Learning access

Job summary

Gilero/Sanner's Carlsbad, CA office is seeking a Senior Product Development Engineer to lead the design, development, and manufacturing transfer of medical devices and combination products. You will drive phase-gate processes, manage risk, and mentor junior engineers to deliver state-of-the-art products that meet customer needs and regulatory requirements.

The role emphasizes cross-functional collaboration with customers, suppliers, and internal teams, with a focus on rigorous documentation,

Qualifications

• 5+ years in medical device product development or related field.
• BS in Engineering or equivalent technical degree.
• Strong ability to translate VOC into design inputs and requirements.
• Familiarity with QMS (ISO 13485, CFR 21) and ISO 14971; ISO 10993 a plus.

Responsibilities

• Act as technical lead for high‑complexity product development across lifecycle.
• Oversee Phase 0–5 from concept to manufacturing transfer.
• Track technical risk and provide engineering guidance.
• Mentor junior engineers and drive team to milestones.
• Develop and review DHF, test methods, and verification/validation plans.
• Inform project budgets with feasibility, prototyping, and validation details.
• Lead smaller technically oriented projects as project manager.

Skills

5+ years product development

Medical device expertise

Team leadership

QMS & regulatory knowledge

Education

Bachelor's degree in Engineering

Job description

Gilero/Sanner's Carlsbad, CA office is seeking a Senior Product Development Engineer to lead the design, development, and manufacturing transfer of medical devices and combination products. You will drive phase-gate processes, manage risk, and mentor junior engineers to deliver state-of-the-art products that meet customer needs and regulatory requirements.

The role emphasizes cross-functional collaboration with customers, suppliers, and internal teams, with a focus on rigorous documentation,