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Job description
Responsibilities 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
- Must have effective communication skills