Senior Medical Device Product Development Lead

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

Benefits offered by this job

Annual bonus

Medical insurance

Dental and vision

Life insurance

Disability insurance

401(k) match

LinkedIn Learning

Job summary

Gilero/Sanner's Durham, NC office is seeking a Senior Product Development Engineer to lead design, development, and production of medical devices and combination products. You will champion DHF development, risk management, and verification/validation efforts across Phase 0–5.

You will collaborate with customers, vendors, and internal teams to deliver high-quality solutions while adhering to QMS standards and regulatory requirements, including ISO 14971/13485 and CFR 21.

Qualifications

• BS in Engineering or equivalent technical degree.
• 5+ years of product development experience in medical devices.
• Experience with ISO 14971, 13485; CFR 21 knowledge.
• Ability to translate VOC into engineering design inputs.

Responsibilities

• Act as a technical lead overseeing products and cross-functional initiatives.
• Manage complex product development from concept to manufacturing transfer.
• Develop and validate test methods and protocols per state-of-the-art requirements.
• Lead risk assessments including FMEAs and residual risk analysis with QA.
• Draft design history files and regulatory submissions.
• Mentor junior engineers and guide technical risk retirement.

Skills

Technical leadership

Project management

Risk analysis

Statistical methods

Communication skills

Education

Bachelor's degree in Engineering or equivalent technical degree

Tools

QMS familiarity

Regulatory documentation

Measurement systems analysis

GD&T knowledge

Job description

Gilero/Sanner's Durham, NC office is seeking a Senior Product Development Engineer to lead design, development, and production of medical devices and combination products. You will champion DHF development, risk management, and verification/validation efforts across Phase 0–5.

You will collaborate with customers, vendors, and internal teams to deliver high-quality solutions while adhering to QMS standards and regulatory requirements, including ISO 14971/13485 and CFR 21.