FREELANCE MECHANICAL DESIGNER

Lead sustenance activities (MLD) and remediation projects Lead and support CAPA investigations with RCA Support ongoing MDD and MDR regulatory compliance projects

Support DHF (design history file) remediation for mechanical engineering deliverables which includes; defining strategy and planning, gap analysis, creating new and revising DHFs, reviewing and releasing DHFs DHFs accountability and responsibility for mechanical and mechatronic parts and sub systems (Gas path, valves, sensors (air, O2 and Pressure), manifold, patient interface, solenoid valves, filters, blowers, motors and enclosure) Review, mentor correctness and approve design documentation including requirements specification, design docs, engineering analysis & simulation studies, calculations, capture, test plans, test procedures, test records & reports Lead project team members to produce development plans and identify and mitigate development risks.

Conceive, design, develop, evaluate, and implement new systems and products in the field of medical ventilator product development and sustaining engineering. Utilize best practices in mechanical design analysis, modeling, and tolerance analysis to produce a highly viable mechanical. Create documentation, including component details, assembly details, incoming and finished inspection requirements, using CAD (Computer Aided Design) as a design tool.

Responsible for all aspects of design documentation including requirements specification, engineering analysis, drawings, test plans/procedures, validation, the release of components, assemblies and products to production, and production start-up support. Supports the manufacturing engineering team in troubleshooting and resolving issues discovered during production.

Be a self-starter, action oriented, organized and disciplined. Keep abreast of technical developments in own field through literature, technical contacts, and industry competition. Work in close co-ordination with PMG and manufacturing engineering for resolution of issues as they arise during sample build phases and actual production Lead & or support CAPA activities for closure of CAPA with effective implementation of containment, corrective and preventive actions.

Lead RCA investigation for any issues arises in the plant or in the field using fish bone diagrams, probable and potential causes, why-why analysis, replicating issues in the lab and taking containment and corrective actions for re-occurrence prevention.,Pune ramp-up to support MLD, CAPA's and MDD & MDR work on respiratory products - RDD, Oxygen, Cough Assist & Trilogy EVO etc.