Mechanical Design Engineer

About the role

OrganOx is seeking a Mechanical Design Engineer to develop mechanical components and assemblies for its medical device platforms. The position is hybrid and based in New Jersey, allowing close collaboration with engineering, quality, and regulatory teams.

Key responsibilities

• Design mechanical components and assemblies for medical devices using CAD tools.
• Support engineering analysis and testing activities for design verification and validation.
• Collaborate with manufacturing and suppliers to ensure designs are practical and manufacturable.
• Assist with prototype builds, testing, and engineering investigations.
• Prepare engineering documentation in accordance with ISO 13485 and other applicable standards.
• Participate in risk management and design review activities.
• Work closely with electrical, software, quality, and manufacturing teams throughout the product development lifecycle.
• Adhere to OrganOx's Code of Conduct and company policies.

Required profile

• Bachelor's degree or higher in Mechanical Engineering or a related field.
• 2‑4 years of mechanical design experience.
• Experience supporting products through development and testing activities.
• Good problem‑solving and communication skills.
• Ability to work effectively within cross‑functional engineering teams.

Required skills

• Proficient in CAD design (SolidWorks preferred).
• Understanding of mechanical design principles, materials, and manufacturing processes.
• Familiarity with engineering analysis and testing methods.
• Experience in regulated industries, preferably medical devices.
• Knowledge of ISO 13485 documentation requirements.