Product Development Engineer

Scorpion Therapeutics; 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

Role: Product Development Engineer leading technical aspects of new or re-designed disposable medical devices in a regulated environment.

Responsibilities include designing and developing devices following design control standards (e.g., 21 CFR 820, ISO 13485), conducting risk analysis, validation, and verification activities, and supporting quality and continuous improvement initiatives.

Key tasks involve cross-functional collaboration with manufacturing, regulatory, marketing, and operations teams to transfer designs into production, develop test protocols, and ensure compliance.

Qualifications: Bachelor’s in mechanical, biomedical, electrical engineering or related; 8+ years’ medical device R&D experience or 3-5 years product development experience in regulated industry; proficiency in SolidWorks, Microsoft Office, and familiarity with standards like ISO 13485 and ISO 14971.

Soft skills include strong analytical, problem-solving, communication, and organizational abilities.

HighValue: Medical devices, regulated environment, design control, risk management, cross-functional collaboration, validation/testing, continuous improvement.

Work setup: not specified; supervisory responsibilities may include overseeing team members.