Senior Staff 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

Role

Lead engineering operations for medical devices at Takeda, focusing on designing, testing, and ensuring compliance of equipment to meet quality, safety, and performance standards.

Responsibilities

Develop standardized protocols, maintain GxP and regulatory compliance, lead technical activities such as test method validation, and collaborate across R&D, QA, and manufacturing teams. Manage external testing labs and suppliers, and provide technical oversight for device qualification and validation activities.

Qualifications

B.S. in engineering with 8+ years or M.S. with 6+ years in medical device testing or combination product development; experience with regulated environments including Design Control (21 CFR 820) and ISO standards; strong expertise in device validation, CAD (SolidWorks), and statistical analysis; knowledge of GMP, GxP, and industry standards (ISO, AAMI). Preferred: PhD, Design for Six Sigma, and experience with injection molding. High-value: focus on combination products, device qualification, validation, and GxP compliance.

Work setup

On-site in Lexington, MA, with potential for controlled environment work; candidates should be prepared for manufacturing environment protocols.