Description

You will design, develop, and verify mechanical components for medical devices within a regulated environment.

This role is on-site.

Responsibilities

• Translate design inputs into engineering specifications for mechanical components.
• Create and refine engineering documentation, including Design History Files, following design controls.
• Apply engineering principles to solve complex challenges and ensure compliance with industry standards.
• Collaborate with R&D, Quality, Regulatory, Manufacturing, and Clinical teams to drive project execution.
• Manage tasks, priorities, and deliverables across multiple projects with minimal supervision.

Required Skills

• Bachelor of Science in Mechanical Engineering, Biomedical Engineering, or a related discipline.
• 5+ years of professional experience in product design and development.
• Proficiency in applying materials and manufacturing processes to product design.
• Ability to create engineering drawings and models using GD&T and CAE tools.
• Knowledge of Quality Management Systems and Risk Management protocols.
• Experience with Project Management workflows.
• Strong technical communication skills for sharing plans and information.

Preferred Skills

• Experience using Creo or other parametric CAD design packages.
• Background working in FDA-regulated or highly regulated industries.

Key Skills

Education

Bachelor's degree