Senior Design Verification Engineer

Job Title: Senior Design Verification Engineer Location: North Chicago, IL Schedule: Hybrid (100% onsite)

Experience: 8 - 10 Years Contract: 1 year (with potential extension) Work Authorization: H1B accepted

Top Skills & Experience Required

Design verification of electromechanical devices

Infusion pump or on-body infuser development / sustaining engineering

Authoring test plans, protocols, and reports

Strong documentation practices

Cross-functional collaboration

Job Description

The Senior Engineer within the Science & Technology (S&T) organization will be responsible for the development, improvement, and verification of electro-mechanical medical devices. This role requires a technical expert who can independently apply engineering knowledge and problem-solving skills to execute design improvements with a high degree of accountability.

Key Responsibilities

Manage device design changes in collaboration with internal teams and manufacturing partners.

Apply risk-based thinking to mitigate potential device failures and defects.

Lead verification testing activities including planning, fixture development, test method validation, protocol creation, and execution.

Oversee multiple concurrent projects, often involving external development partners.

Propose and implement device refinements based on patient feedback, manufacturing records, and stakeholder input.

Perform engineering analyses (e.g., tolerance analysis, calculations) to improve designs.

Lead or support root cause investigations and provide design solutions for complex problems.

Ensure compliance with applicable standards (IEC 60601-1:2020, ISO 10993-1:2018) and internal procedures.

Maintain device history files with accurate documentation.

Conduct early risk assessments and implement fallback strategies to ensure project success.

Some travel may be required.

Qualifications

• Bachelor’s degree in Engineering required; Master’s or higher preferred.

• 8+ years of significant engineering experience (medical devices preferred).

• Demonstrated track record of technical contributions and accomplishments.

• Strong collaboration skills with internal teams and external partners.

• Proficiency in SolidWorks .