SME- Orthopedics

Role Overview:

As a Domain Expert in Orthopedics, you will be required to play a pivotal role in shaping the future of digital and robotic surgery solutions for global leading Medtech companies , by bridging clinical insight with cutting-edge technology. This role demands expertise in orthopedic procedures ,digital surgical and robotic systems, combined with the added ability to collaborate across Product Lifecycle Management (PLM), Manufacturing Execution Systems (MES), and Clinical teams.

Required Skills:

Readiness to work from office all 5 days a week with minimum productive hours of 9 hrs/day.(Non Negociable)

Must have knowledge/experience in Medial & Life Science domain with exposure to IEC62304, ISO13485 compliances, SOUP/COTS tool validation, Design Histroy File etc (Non Negociable)

BE (preferably in Biomedical engineering) with over 12-14 plus years experience / MTech( Biomedical) with 12-14 plus years experience, MBBS MTech/MMST with over 10-12 years experience, working in the Medical devices industry or with Engineering services providers.

Bring in Specialization in working in key Speciality of Orthopedics with knowledge of orthopedic procedures in areas like joint reconstruction, Sports medicine, digital surgical workflows, and robotic systems..

Experience with surgical navigation, intraoperative imaging, and AI-driven surgical planning will be a major advantage

Experience in understanding and execution of projects involving medical standards like DICOM and HL7/FHIR with ability to Guide integration of such Orthopedics platforms with hospital systems (EMR, PACS etc)

Should possess good presentation, communication and documentation skills with good team building and leadership abilities.

Ability to work closely with cross functional teams in organization

Experience with Regulated environments like FDA, ISO 13485,HIPAA, GDPR will be essential

Possess good balance of domain and technology skills to work closely with technology COEs for solution identification and implementation.

Good understanding of regulatory landscape of the Medical device industry globally

Experience in development of robotic assisted surgical solutions in Orthopedics or for any other specialty will be an added advantage

Good understanding and implementation experience of digital health platforms for medical industry segments

Job Responsibilities:

Engage with client stakeholders to drive value conversations based on market trends, competitor analysis and technology trends

Provide domain trainings to the team in terms of integrated surgical workflows in hospitals across the various stages of surgical workflow, Surgical kit workflow management , Human anatomy etc

Business Development Support: Prepare RFX responses (RFP/RFI) proactive and reactive; create bid defense presentations

Creation of marketing collaterals like case studies and brochures and contribute to white papers, Blogs, POV etc

Take learning from current projects or engagements and document the best practices, strategies which worked well

Collaborate cross-functionally with delivery, sales, and solution teams to build on value proposition for customer

Conduct in-depth research on the prospect/ account and provide inputs/insights on business synergies & possible opportunities, strategy/focus areas, outsourcing landscape, including research and analysis on competitors, trends in medical industry and its implications for client.

Make a collaborative approach to exchange knowledge and foster innovation: Engage with academia, hospitals, clinicians as required

Work closely with the leadership team to create strategy/ planning presentations and provide other presales support to account teams and as required

Stay updated on regulatory requirements affecting the orthopedics industry like FDA, EU MDR ...

Ability to collaborate across PLM, MES, and Clinical and IT teams to architect integrated solutions that enhance product innovation, manufacturing efficiency, and clinical outcomes could be a added advantage