Vijaykaartik Kumar
Seasoned leader with Experience in the Medical Device Industry, Adept at Leading Engineering & Technical Teams to Drive Innovation & Achieve Business Objectives
- Role
- Sr Engineering Manager, Product Safety at Stryker
- Location
- Portage, MI, US
- LinkedIn followers
- 500 followers
About Vijaykaartik Kumar
Passionate and results-oriented, I’ve demonstrated success in coaching employees and fostering a culture of continuous learning and growth. As a seasoned leader, my proven track record in resource management and strategic planning, particularly in Quality Assurance, ensuring adherence to regulatory standards and optimizing processes for efficiency and effectiveness. I am experienced in FDA 21 CFR 820 (QSR) design control guidance, risk management ISO-14971, IEC 62366-1, and quality systems. My skill as a divisional process owner and Subject Matter Expert (SME) for external and internal audits is enhanced by a Project Management certification and leadership development training on building an inclusive culture and resilient teams. With a comprehensive understanding of the medical device industry landscape, regulatory standards, and best practices, I am well-equipped and dedicated to driving innovation, quality, and compliance in dynamic and challenging environments.
Experience
Sr Engineering Manager, Product Safety
Dec 2025 — Present · US
Education
University of Nevada-Las Vegas
Masters, Mechanical Engineering
2003 — 2005
University of Madras
B.E, Mechanical Engineering
1998 — 2002
Skills
- People Management
- Design for Manufacturing
- Iso 13485
- Iso 14971
- Pro Engineer
- Medical Devices
- Biomedical Engineering
- Fda
- Quality System
- Fmea
- Project Management
- Solidworks
- Design Control
- Contract Manufacturing
- Geometric Dimensioning & Tolerancing
- Product Development
- R&D
- Ptc Creo
- Team Leadership
- Design of Experiments
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