Senior R&D Engineer

Staftonic LLC; North Carolina; On-site; USD 90,000 - 130,000; Full time

Job summary

Staftonic LLC is seeking a lead engineer to oversee medical device product development from feasibility through DV and manufacturing transfer. You will apply design controls and risk management across the lifecycle, develop test methods, and ensure proper documentation.

This role requires hands-on lab and manufacturing work, strong problem-solving, and effective communication with engineering, quality, and regulatory teams, including offshore collaboration as needed.

Qualifications

• Experience in medical device product development or R&D engineering.
• Strong knowledge of design controls, DHF, risk management, and design verification/validation.
• Experience developing and executing engineering test protocols and test methods.
• Familiarity with IQ/OQ/PQ and simulated-use testing.
• Ability to create and interpret engineering drawings, specifications, and technical documentation.
• Strong problem-solving and root-cause analysis skills.
• Comfortable working hands-on in both laboratory and manufacturing environments.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Lead product and design changes from feasibility and prototyping through Design Verification (DV) and manufacturing implementation.
• Apply design controls, risk management, and structured engineering documentation throughout the product lifecycle.
• Develop, validate, and execute engineering test methods, including simulated-use testing.
• Develop and execute IQ/OQ/PQ protocols as required.
• Create and maintain engineering drawings, specifications, DHF documentation, and other technical records.
• Support troubleshooting and root-cause investigations on the manufacturing floor and in the laboratory.
• Communicate technical decisions, project status, risks, and issues to engineering stakeholders.
• Provide technical direction and review work performed by an offshore engineering team.
• Collaborate with Engineering, Quality, Manufacturing, Regulatory, and other cross-functional teams.

Skills

Medical device development

Design controls

Test protocols

IQ/OQ/PQ

Engineering drawings

Root-cause analysis

Lab & manufacturing

Cross-functional collaboration

Job description

• Lead product and design changes from feasibility and prototyping through Design Verification (DV) and manufacturing implementation.
• Apply design controls, risk management, and structured engineering documentation throughout the product lifecycle.
• Develop, validate, and execute engineering test methods, including simulated-use testing.
• Develop and execute IQ/OQ/PQ protocols as required.
• Create and maintain engineering drawings, specifications, DHF documentation, and other technical records.
• Support troubleshooting and root-cause investigations on the manufacturing floor and in the laboratory.
• Communicate technical decisions, project status, risks, and issues to engineering stakeholders.
• Provide technical direction and review work performed by an offshore engineering team.
• Collaborate with Engineering, Quality, Manufacturing, Regulatory, and other cross-functional teams.

Required Qualifications:

• Experience in medical device product development or R&D engineering.
• Strong knowledge of design controls, DHF, risk management, and design verification/validation.
• Experience developing and executing engineering test protocols and test methods.
• Familiarity with IQ/OQ/PQ and simulated-use testing.
• Ability to create and interpret engineering drawings, specifications, and technical documentation.
• Strong problem-solving and root-cause analysis skills.
• Comfortable working hands-on in both laboratory and manufacturing environments.
• Strong communication and cross-functional collaboration skills.

Preferred Experience:

• Catheter-based or minimally invasive medical devices
• Compliant balloon catheters
• Biopsy needles
• Design transfer / manufacturing implementation
• Technical leadership or experience guiding engineering teams