Senior Staff Engineer

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.