Device Engineer III

Device Engineer III – Testing, Method Development, Design Verification & Method Transfer Job Responsibilities: Support design control activities, including design verification, design transfer and risk‑management deliverables. Develop, optimize, and validate test methods for device and combination‑product components. Execute design verification (DV) testing; prepare protocols, data summaries, and technical reports. Assist with method transfers between internal labs, external DV labs, and manufacturing sites. Coordinate and monitor external testing to ensure methods, protocols, and data meet quality/compliance standards. Contribute to lab operations (equipment readiness, sample coordination, 5S/Kaizen). Support quality investigations related to testing activities (deviations, CAPAs, change controls). Represent Device Engineering in internal meetings, supplier interactions, and project forums. Communicate technical findings clearly with cross‑functional partners. Basic Qualifications Doctorate OR Master’s and 3+ years relevant experience OR Bachelor’s and 5+ years relevant experience. Preferred Qualifications / Skills BS/MS in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or related field. Experience in combination product development, medical device testing, or pharma/biotech environments. Hands‑on: test method development/validation, design verification testing, characterization/performance testing for combination products. Knowledge of design control, risk management, and regulatory standards (FDA, ISO13485, ISO14971, cGMP). Familiarity with ISO11040, ISO11608, ISO80369. Statistical techniques/software (ANOVA, Gauge R&R, sample size; JMP, Minitab). Strong technical communication; troubleshoot, root‑cause investigate, drive continuous improvement. Compensation & Benefits Salary range: $117,895.00 – $152,570.00; may include discretionary annual bonus, stock‑based long‑term incentives, paid time off, and company‑sponsored medical, dental, vision, and life insurance plans. #J-18808-Ljbffr Scorpion Therapeutics