Description

Key Responsibilities

Manage and execute Change Controls (MOCs) from request through closeout using Master Control.

Perform CAD design updates in SolidWorks for device components, ranging from minor to complex changes.

Support manufacturing floor operations by troubleshooting issues, identifying root causes, and implementing corrective actions.

Conduct verification activities including protocol documentation, execution, and final reporting.

Perform part measurements and statistical analysis to assess tolerance changes and assembly stack‑ups.

Route supporting documentation into Master Control, ensuring SOP compliance and traceability.

Design, specify, and build mechanical enclosures, components, and test fixtures.

Collaborate with cross‑functional teams (OPS, Quality, Engineering, Technicians) to ensure project coordination.

Maintain compliance with GDP/GMP standards and safety protocols.

Estimate material and labor requirements for mechanical projects and repairs.

Required Skills

Strong proficiency with SolidWorks CAD and mechanical design.

Experience with machined metal, plastic, and sheet metal parts.

Ability to read schematics/drawings and build test fixtures.

Hands‑on experience with verification, statistical analysis, and tolerance assessments.

Strong troubleshooting and problem‑solving skills.

Excellent communication and teamwork abilities; able to multitask and pivot priorities in a fast‑paced environment.

Preferred Skills

Geometric Dimensioning & Tolerancing (GD&T) experience.

Project management experience with short‑ to mid‑range projects.

Familiarity with Windows‑based test systems.

Prior experience in medical device or regulated industries.

Education Requirement: Bachelor’s degree in Mechanical Engineering or related field; 5–10 years of experience preferred

Key Skills

Education

Bachelor's degree