Work Flexibility: HybridResponsibilities and duties
Work as Product Development point of contact for Packaging related projects for Joint Replacement sustaining products.
Scope of products are both Implants and instruments with technical complexity ranging for low to high based on the skill set and scale of stakeholders involved.
Contribute to scoping, analyzing gap in current design by challenging to improve in areas manufacturing, inspection, GD&T, Tol. Stack up, V&V, design documents
Knowledge of Packaging material selection will be an added advantage.
Establish cadence and framework in place to deliver on projects working with global and local partner functions like AO and external stakeholders like vendors
Key skills post scoping will need execution of such projects to
Complete/update design, drawings, design controls, Verification and Validation activities ( Must Have). Writing testing protocol and test reports will be good to have. Driving NC, CAPA, SOFHA, TA closure wherever applicable - Good to have.
Conduct reviews, meetings with the internal/external stakeholders to monitor progress of projects and provide guidance, develop contingent plans, leading technical discussion with ability to take technical decision by their own while considering various inputs.
Communicating frequently across all project disciplines to ensure project team and senior management are aware of upcoming milestones and risks/issues.
Effective communication and knowledge of compliance regulations and standards, including 21CFR820, ISO 13485, ISO 14971 throughout the design and development process
Experience/skills required * BE/B.Tech/ME/M. Tech in Mechanical Engineering
3-5 years of relevant work experience.
Experience and hands on with design tools like Creo, Solidworks, Windchill.
Skilled in interpreting design, analyzing, and doing DFM, DFI, materials and manufacturing.
Working level of GD&T and tolerance analysis
Understanding of medical domain and clinical setting.
Passion to lead self, believe in driving growth by initiatives and value add, skills and team player