About Company
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. KIMIA Recover was the first product of Kinexcs launched in the market, a continuous monitoring device for the knee joint, which has obtained FDA Approval, CE marking, and HSA approval. Key customers include large implant companies, hospitals, healthcare and wellness groups. The product is a winner of the Johnson and Johnson Quickfire Challenge Award, James Dyson National Award Singapore, and CHI Innomatch grant supported by the Temasek Foundation. The digital product, KIMIA Assess, uses artificial intelligence technology for digital 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 in the region.
We are looking for a contract-based consultant who will be providing the following technical guidance and support.
Roles and responsibilities
Technical Training & Mentorship
- Conduct training sessions on FMEA, process validation (IQ/OQ/PQ), basic statistics, Six Sigma/Lean, line balancing, takt time, 8D problem solving, engineering study reporting, and Minitab statistical analysis.
- Mentor internal staff to strengthen technical knowledge, quality system understanding, and manufacturing process capability.
Manufacturing Contract Development
- Support the drafting and refinement of the manufacturing contract agreement between Kinexcs and the production partner.
- Support in defining the scope, quality requirements, acceptance criteria, delivery timelines, confidentiality, IP protection, and escalation processes.
Document Review & Validation
- Review manufacturing documentation from the contract manufacturer, including validation plans, inspection criteria, and control plans.
- Ensure documents meet Kinexcs requirements and align with quality and process standards.
- Consolidate feedback and support approval of documentation packages.
QMS Documentation Development
- Assist in developing production-related Standard Operating Procedures (SOPs), Work Instructions, and Quality Management System documents.
- Align manufacturing and quality documentation with Kinexcs QMS framework and medical device standards.
Technical Support for Process Issues
- Provide guidance in root cause analysis sessions for process-related issues.
- Recommend corrective and preventive actions (CAPA) and support verification of effectiveness.
- Assist in documenting issue-resolution reports and validated process improvements.
- Collaborate with both Kinexcs and Production Partner on resolving manufacturing process challenges.
General Project Support
- Coordinate with internal stakeholders and the manufacturing partner to facilitate training, document reviews, and process improvement tasks.
- Ensure deliverables such as training reports, validated documentation, and process improvement are completed as required.
Qualifications
- Bachelor's degree in Engineering (Mechanical, Manufacturing, Industrial, Biomedical, or related field).
- 5+ years of experience in manufacturing or quality systems, preferably in medical devices or other regulated industries.
- Strong knowledge of ISO 13485, process validation (IQ/OQ/PQ), and quality system documentation.
- Hands-on experience with Lean / Six Sigma methodologies (Green Belt or higher preferred).
- Practical experience with FMEA, CAPA, NCR management, 8D structured problem solving, and root cause analysis techniques.
- Ability to train and mentor teams on technical and quality topics, including statistics and process improvement.
- Excellent skills in technical documentation, SOP writing, and communication when collaborating with contract manufacturers.
