Senior Medical Device Product Development Lead

Gilero; Chicago (IL); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Annual bonus

Medical insurance

Dental & Vision

Life insurance

Disability insurance

401(k)

Job summary

Gilero is seeking a Senior Product Development Engineer for medical devices to lead design, development, and production efforts. The role focuses on idea generation, verification, validation, and DHF development aligned with state‑of‑the‑art requirements.

You will work with customers, vendors, and internal teams to ensure high‑quality outcomes in a fast‑paced environment. Office presence is required four days a week at the Chicago, IL site.

Qualifications

• BS in Engineering or equivalent technical degree.
• 5+ years of product development experience in medical device or similar space.
• Deep ISO 14971, 13485 and CFR 21 knowledge; ISO 10993 a plus.
• Experience with risk management, FMEAs, and residual risk analysis.
• Ability to translate VOC into engineering inputs and outputs.
• Strong documentation for DHF, design history files, and regulatory submissions.

Responsibilities

• Act as a technical lead with project oversight for devices and cross‑functional initiatives.
• Manage high‑complexity development deliverables through lifecycle from concept to manufacturing transfer.
• Track technical risk and provide engineering guidance.
• Mentor junior engineers and lead the team through risk retirement.
• Develop test methods, protocols, and verification/validation plans.
• Prepare budgets with feasibility, prototyping, verification, and validation considerations.
• Act as project manager for smaller technically oriented projects.

Skills

Product development

Medical device

Regulatory knowledge

Risk analysis

FMEAs

Design verification/validation

GDP/GxP understanding

ISO 14971/13485 knowledge

CFR 21 CFR awareness

GD&T knowledge

QMS processes

Leadership/mentorship

Education

BS in Engineering or equivalent technical degree

Tools

Statistical methods

Measurement systems analysis

Job description

Gilero is seeking a Senior Product Development Engineer for medical devices to lead design, development, and production efforts. The role focuses on idea generation, verification, validation, and DHF development aligned with state‑of‑the‑art requirements.

You will work with customers, vendors, and internal teams to ensure high‑quality outcomes in a fast‑paced environment. Office presence is required four days a week at the Chicago, IL site.