Senior Fractional Manufacturing Expert

<p><strong>Company Overview:</strong></p><p><br></p><p>Kinexcs is an AI-driven digital health platform and wearables company with a mission to enable and empower people for mobility and a better quality of life. It is focused on reducing the burden of musculoskeletal conditions, which affects about 25% of the world’s population. The flagship product, KIMIA Recover, a continuous monitoring device for the knee joint, has obtained FDA Approval, CE marking and HSA approval. KIMIA Recover is a comprehensive recovery management solution providing reduction in number of hospital visits and complications for knee patients.</p><p><br></p><p>Kinexcs' digital platform uses artificial intelligence for MSK assessment and therapy. This platform is capable of providing pre-consultation assessments and real-time exercise guidance and feedback to musculoskeletal patients, and is being adopted by some of the largest private healthcare providers and corporates</p><p><br></p><p><strong>Role Purpose:</strong></p><p>Kinexcs is seeking an experienced manufacturing expert on a fractional basis to provide independent technical oversight for the upcoming KIMIA Recover production run. The expert will review readiness, identify blind spots, challenge supplier inputs, guide the resolution of complex production issues and provide clear direction at key decision points.</p><p>The ideal candidate combines hands-on manufacturing experience with strong judgement in regulated medical-device production, process validation, supplier management and quality controls. </p><p><br></p><p><strong>Key Responsibilities</strong>:</p><p><br></p><ul><li><strong>Production readiness and risk review. </strong>Review the production plan, manufacturing flow, build sequence, BOMs, drawings, work instructions, supplier handoffs, inspection points and quality gates. Identify manufacturability, assembly, process, quality and schedule risks before production release, and recommend practical mitigation actions.</li><li><strong>Supplier and contract manufacturer oversight. </strong>Review supplier technical proposals, process plans, first-article or inspection results, validation evidence and proposed process changes. Advise what evidence is required, which issues should be escalated and whether proposed actions are technically adequate.</li><li><strong>Process validation and production controls. </strong>Review validation strategy and relevant plans, protocols, engineering studies and IQ/OQ/PQ reports. Advise on inspection criteria, traceability, production records, nonconforming product handling and release readiness in alignment with ISO 13485 and Kinexcs' quality system.</li><li><strong>Troubleshooting and technical decision-making. </strong>Support root-cause analysis, containment, disposition, and corrective or preventive actions for complex manufacturing and quality issues. Provide clear go/no-go recommendations and senior technical guidance on critical manufacturing matters, with the rationale and recommended follow-up actions clearly documented. </li><li><strong>Mentoring, on-site support and knowledge transfer. </strong>Provide practical mentoring to strengthen the internal team's manufacturing knowledge and decision-making. Attend critical supplier meetings or production-site reviews when hands-on assessment is needed, and help the team convert lessons learned into stronger processes, controls and future production decisions.</li></ul><p><br></p><p><strong>Expected Deliverables:</strong></p><p><br></p><ul><li>Production readiness assessment with a prioritised gap, risk and action list.</li><li>Written review comments on supplier proposals, validation outputs, inspection data and process changes.</li><li>Clear technical recommendations or go/no-go decisions for critical production matters.</li><li>Troubleshooting support, including root-cause, containment, corrective-action and issue-closure recommendations.</li><li>A concise milestone or engagement summary covering unresolved risks, decisions made and recommended next steps.</li></ul><p><br></p><p><strong>Required Experience and Qualifications:</strong></p><p><br></p><ul><li>Degree in manufacturing, mechanical, industrial, biomedical, electrical engineering or a related discipline.</li><li>Substantial senior-level, hands-on experience in manufacturing engineering, new product introduction, industrialisation, operations or technical production leadership.</li><li>Proven experience taking physical products through production transfer, pilot or low-volume builds, process validation, contract manufacturing and production ramp-up.</li><li>Strong working knowledge of DFM/DFA, PFMEA/FMEA, process capability, measurement-system analysis or Gauge R&R, inspection planning, root-cause analysis and production risk management.</li><li>Experience reviewing drawings, BOMs, work instructions, supplier proposals, validation data, inspection results, deviations and process changes.</li><li>Strong familiarity with ISO 13485, medical-device production controls, traceability, nonconformance/CAPA and disciplined production documentation.</li><li>Demonstrated ability to make sound decisions under ambiguity, communicate clearly and provide practical recommendations that internal teams and suppliers can execute.</li><li>Availability to provide timely fractional support and attend production sites when required.</li></ul><p><br></p><p><strong>Preferred Background:</strong></p><p><br></p><ul><li>Experience with regulated medical devices, wearable or rehabilitation technology, or electromechanical and sensor-based products.</li></ul><p><br></p><p><strong>Engagement Expectations:</strong></p><p><br></p><p>Hours and availability will be agreed around planned production milestones and ad hoc escalations. The successful expert should be comfortable working flexibly, responding promptly when critical issues arise, and providing concise written recommendations that support accountable decision-making.</p><p><br></p>