Job Description

• Experience in Medical Device Product Development
• Experience in coordinating with offshore teams, preferably experience of working with teams in India
• Expertise in CAD software UG NX and Teamcenter Engineering or similar CAD software is must
• Experience in tolerance stack up analysis, FEA analysis, concept development
• Experience of working through Design Control Process for NPD
• Exposure to Medical Device Risk Management per ISO 13485. Hands on experience in Design Failure Mode and Effect Analysis (DFMEA)
• Significant experience of Project & Program Management concepts, and the associated tools
• Exposure to Design Verification and Validation activities
• Good understanding of Medical Device QMS and Design Quality requirements
• Understanding of Design History File (DHF)
• Basic understanding of regulatory pathways in various key geographies for various classes of medical devices
• Significant grasp over key concepts, requirements & terms associated with product re-certification activities for FDA, BSi & MDD-EEC.
• Orthopaedic and Spine Product knowledge will be an advantage
• Take ownership and draft various aspects of DHF
• Conceptualize new design and propose creative solutions to solve design problems
• Ensure compliance with statutory or company regulatory requirements
• Ensure Design Verification and Validation is performed to demonstrate safety and efficacy of new design
• Plan and execute Risk Management and perform DFMEA
• Interact with all levels of company management, external experts and vendors
• Assume responsibility for own commitments & delivering to agreed timescales per project deadlines
• Provide updates to company management regarding work performed & deliverables
• Create and manage Engineering Change Orders if required
• Make use of the offshore team, based in various locations, with prior approval of the concerned line manager(s)