Senior Medical Device Product Development Engineer

Delcath Systems, Inc.; Town of Queensbury (NY); On-site; USD 120,000 - 180,000; Full time

Job summary

Scorpion Therapeutics is seeking a Product Development Engineer to lead technical aspects of disposable medical devices in a regulated environment. You will design and develop devices under design controls, perform risk analysis, validation and verification, and collaborate across manufacturing, regulatory, marketing and operations to transfer designs into production.

The role requires a Bachelor’s in engineering and extensive experience in medical device R&D or regulated product development,

Qualifications

• Bachelor’s degree in mechanical, biomedical, electrical engineering or related field.
• 8+ years of medical device R&D experience or 3–5 years in regulated product development.
• Proficiency in SolidWorks and Microsoft Office.
• Familiarity with ISO 13485 and ISO 14971.

Responsibilities

• Lead design and development of disposable medical devices under design controls.
• Perform risk analysis, validation, and verification activities.
• Collaborate with manufacturing, regulatory, marketing, and operations to transfer designs to production.
• Develop test protocols and support quality and continuous improvement initiatives.

Skills

Analytical skills

Problem-solving

Communication

Organizational skills

Education

Bachelor’s in mechanical, biomedical, electrical engineering or related

Tools

SolidWorks

Microsoft Office

Job description

Scorpion Therapeutics is seeking a Product Development Engineer to lead technical aspects of disposable medical devices in a regulated environment. You will design and develop devices under design controls, perform risk analysis, validation and verification, and collaborate across manufacturing, regulatory, marketing and operations to transfer designs into production.

The role requires a Bachelor’s in engineering and extensive experience in medical device R&D or regulated product development,