Senior Medical Device Development Leader

RiseMe; Durham (NC); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Annual bonus plan

Medical insurance

401(k) with match

Job summary

Gilero/Sanner in Durham, NC seeks a Senior Product Development Engineer to lead design, development, and production of medical and combination devices. You will drive idea generation, verification, validation, and DHF development to state-of-the-art requirements.

Join a mission-driven team focused on patient outcomes and quality outcomes, with responsibilities spanning cross-functional collaboration with customers, vendors, and internal teams.

Qualifications

• 5+ years of product development experience in medical device or related space.
• Knowledge of design controls, risk management, and QMS.
• Ability to translate VOC into design inputs and outputs.

Responsibilities

• Act as a technical lead for development of medical devices and combinations.
• Manage high-complexity development deliverables from concept through transfer to manufacturing.
• Track risk and provide engineering guidance.
• Mentor junior engineers and guide the team through risk retirement.
• Prepare DHF documents, test methods, and validation protocols.

Skills

Project leadership

translating requirements

Technical risk management

Design verification/validation

Communication

Education

BS in Engineering or equivalent

Tools

GD&T

Job description

Gilero/Sanner in Durham, NC seeks a Senior Product Development Engineer to lead design, development, and production of medical and combination devices. You will drive idea generation, verification, validation, and DHF development to state-of-the-art requirements.

Join a mission-driven team focused on patient outcomes and quality outcomes, with responsibilities spanning cross-functional collaboration with customers, vendors, and internal teams.