Electromechanical Engineer
Akraya
Contract Device EngineerWe are seeking a contract Device Engineer to support design development and lifecycle management for commercialized drug delivery devices and electromechanical combination products. The ideal candidate brings hands-on expertise in design control, testing, and experience with medical devices or combination products in a highly regulated pharma environment.Key Responsibilities:Provide lifecycle management (LCM) support for combination products including post-market activities, design improvements, and cross-functional issue resolutionLead complaint investigations by performing failure analysis, identifying root causes, and developing corrective action plansDrive and manage CAPAs, deviations, and change controls ensuring compliance with regulatory and quality system requirementsCollaborate with external suppliers and cross-functional teams (R&D, Quality, Regulatory, Manufacturing) for design reviews and continuous improvementLead design verification activities including test protocol development, execution, and technical documentationPerform data analysis, traceability reviews, and on-site testing for electromechanical delivery systemsMust-Have Skills:Bachelor's or Master's degree in Engineering (Mechanical, Biomedical, or Electrical) with 3-5 years in a highly regulated environmentStrong preference for medical device, biopharma, and/or combination product experience with electromechanical systemsExpertise in design control, design verification, CAPA processes, and regulatory compliance (21 CFR 820.30, ISO 13485)Proficiency in data analysis, statistical tools (Minitab preferred), and technical documentation
Vacancy posted 1 day ago
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