Senior Manufacturing Engineer – Medical Device

Job Title: Senior Manufacturing Engineer – Medical Device (Implants)Location: Mid-Atlantic / Northeast, United States (Hybrid)Duration: 1 Year contractJob Summary:We are seeking an experienced Senior Manufacturing Engineer to support a leading medical device manufacturing organization. This role focuses on implantable medical devices, with strong involvement in metal machining processes and supplier change management. The ideal candidate will work cross-functionally with internal teams and external suppliers to ensure successful execution of manufacturing and supplier initiatives.Key Responsibilities:Review and assess supplier change requests for manufacturing processes and componentsCollaborate with R&D, Quality, Regulatory, and Supply Chain teams to evaluate impact and ensure complianceSupport metal machining/manufacturing processes related to implantable devicesCoordinate with external suppliers and contract manufacturers for change implementationLead or support process improvement and continuous improvement initiativesEnsure compliance with medical device regulations and quality standards (FDA, ISO)Provide technical guidance and drive project execution across cross-functional teamsMaintain documentation related to change control, validation, and risk assessmentRequired Qualifications:Bachelor’s degree in Mechanical, Manufacturing, or related Engineering field5+ years of experience in medical device manufacturing, specifically implantable devicesStrong experience in metal machining/manufacturing processesHands-on experience with supplier change management / supplier quality engineeringKnowledge of FDA regulations and ISO standards (e.g., ISO 13485)Excellent communication and stakeholder management skillsPreferred Qualifications:Experience with orthopedic, spine, trauma, or surgical implantsBackground with leading companies in implantable medical devicesStrong project management or leadership experienceFamiliarity with validation processes (IQ/OQ/PQ) and risk managementKey Skills:Manufacturing EngineeringSupplier Change ManagementMetal MachiningGMP / Regulatory ComplianceCross-functional CollaborationProcess Improvement