Senior Staff Engineer
Scorpion Therapeutics
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.
#J-18808-LjbffrVacancy posted 7 hours ago
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