Description

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

Responsibilities

• Research and design mechanical components by translating design inputs into engineering specifications.
• Create and refine engineering documentation, including Design History Files, following design controls and risk management protocols.
• 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 your own tasks, priorities, and deliverables across multiple projects with minimal supervision.

Required Skills

• Bachelor of Science in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.
• 5+ years of professional experience.
• Experience in product design and product 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.
• Experience with Project Management workflows.
• Strong technical communication skills for sharing plans and information with team members.

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