Senior Medical Device Validation & Compliance Engineer

Scorpion Therapeutics; Lexington (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Takeda is seeking a Lead Engineer to oversee operations for medical devices, focusing on design, testing, and ensuring compliance with quality, safety, and performance standards. You will develop protocols, maintain GxP compliance, and lead activities like test method validation while collaborating with R&D, QA, and manufacturing teams.

The role requires substantial experience in regulated environments, device validation, and CAD with SolidWorks, plus strong statistical analysis skills.

Qualifications

• Engineering degree with 8+ years in medical device testing or 6+ years with an MS.
• Experience in regulated environments, Design Control (21 CFR 820) and ISO standards.
• Strong expertise in device validation and statistical analysis.

Responsibilities

• Lead engineering operations for medical devices, focusing on design, testing, and compliance.
• Develop and maintain standardized protocols, ensure GxP and regulatory compliance.
• Collaborate across R&D, QA, and manufacturing; manage external labs and suppliers.
• Provide technical oversight for device qualification and validation activities.

Skills

Medical device testing

Design control

CAD SolidWorks

Statistical analysis

GxP compliance

ISO standards

Regulated environments

Education

B.S. in engineering

M.S. in engineering

PhD preferred

Tools

SolidWorks

Job description

Takeda is seeking a Lead Engineer to oversee operations for medical devices, focusing on design, testing, and ensuring compliance with quality, safety, and performance standards. You will develop protocols, maintain GxP compliance, and lead activities like test method validation while collaborating with R&D, QA, and manufacturing teams.

The role requires substantial experience in regulated environments, device validation, and CAD with SolidWorks, plus strong statistical analysis skills.