Senior Medical Device Development Engineer

Sanner America (formerly Gilero); Durham (NC); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Annual bonus

Medical insurance

Dental and vision insurance

Life insurance

Short-term and long-term disability

401(k) with company match

LinkedIn Learning access

Job summary

Sanner America (formerly Gilero) in Durham, NC is seeking a Senior Product Development Engineer to lead design, development, and production of medical devices and combination products. You will focus on idea generation, verification, validation, and DHF development to meet state-of-the-art requirements.

You will guide a team through the full development lifecycle, manage complex projects, and contribute to V&V strategies while ensuring compliance with QMS and regulatory standards.

Qualifications

• BS in Engineering or equivalent technical degree.
• 5+ years of product development experience in medical device, combination product or similar space preferred.
• Ability to translate VOC into engineering design inputs and outputs.

Responsibilities

• Act as a technical lead with project oversight of products, accessories, and cross-functional initiatives.
• Manage product development deliverables through the entire lifecycle from concept to manufacturing transfer.
• Lead the development team through risk retirement and guide root cause analysis.

Skills

Medical device development

Product development lifecycle

Technical leadership

Risk management (ISO 14971)

Education

BS in Engineering

Tools

GD&T

FMEA

Statistical analysis

Gage R&R

Job description

Sanner America (formerly Gilero) in Durham, NC is seeking a Senior Product Development Engineer to lead design, development, and production of medical devices and combination products. You will focus on idea generation, verification, validation, and DHF development to meet state-of-the-art requirements.

You will guide a team through the full development lifecycle, manage complex projects, and contribute to V&V strategies while ensuring compliance with QMS and regulatory standards.