Senior Design Engineer TQA-422

Senior Design Engineer TQA-422

21 Dec

21 Dec



Job Description

Builds organizational capability. A strategic executive who continuously breaks down barriers, identifying new and more effective ways to accomplish tasks and goals.

Inspires others. A genuine, relationship-focused leader who connects, collaborates and fosters an inclusive environment of enthusiasm, trust and pride. He/she makes others want to follow, building momentum for action and positively influencing outcomes.

Champions talent development. A manager who focuses on maximizing the ability, potential and contributions of themselves and others. Fosters an environment where people can excel through developing, coaching and rewarding performance.

Delivers results.

A driven player/coach who sets high goals for personal achievement and organizational success. He/she measures success against the best internal and external benchmarks.

Responsibilities and duties

Work as Product Development point of contact for Packaging related projects for joint replacement products.

Scope of products are Implants, instruments and packaging with technical complexity ranging for low to high based on the skill set and scale of stakeholders involved.

Contribute in scoping, analyzing gap in current design by challenging to improve in areas manufacturing, inspection, GD&T;, V&V;, design documents

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 (setting up and running test at lab facility) Writing testing protocol and test reports Driving NC, CAPA, SOFHA, TA closure wherever applicable.

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

4-6 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

Prior 2 years of packaging experience will be an added advantage

The original job offer can be found in Kit Job:

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