RAHUL SONI
Ahmedabad
Summary
Accomplished Staff Engineer with expertise in New Product Development and project management. Demonstrated ability to enhance project efficiency through proactive risk evaluation and stakeholder communication. Proficient in mechanical risk management (ISO 14971) and skilled in cross-functional collaboration, driving successful outcomes in complex orthopedic device projects.
Overview
13
13
years of professional experience
Work History
Staff Engineer
Shalby Advanced Technology
08.2024 - 03.2025
- Led the development project for Primary Knee Instruments encompassing 200+ SKUs, including project planning, timeline management, stakeholder communication, coordination of team meetings, and regular progress reporting to the Business Unit (BU).
- Improved project efficiency by streamlining communication between team members and stakeholders.
- Evaluated potential risks proactively during project planning stages, allowing for proper mitigation measures to be put in place early on.
- Scoped project timelines accurately by leveraging strong analytical skills, enabling successful delivery within deadlines.
- Presented technical findings and recommendations to key stakeholders with clarity, supporting informed decision-making processes.
- Contributed to the development of new products by conducting extensive research on emerging technologies and market trends.
Senior Engineer
Stryker
07.2023 - 08.2024
- Led quality engineering activities throughout the full product development lifecycle, ensuring compliance with Design Control and PDP (Product Development Process) requirements.
- Collaborated with cross-functional teams to develop and review Critical to Quality (CTQ) characteristics, Design Inputs/Outputs , and risk management documentation.
- Supported development and execution of design verification and validation (V&V) protocols , including usability, reliability , and performance testing aligned with regulatory and safety standards.
- Facilitated test method validations (TMV) and fixture qualifications , ensuring test systems met required accuracy, reliability, and repeatability.
- Co-led FMEA sessions (Design and Use FMEA) and risk management activities , contributing to robust Hazard Analysis , and ensuring compliance with ISO 14971 .
- Participated in and contributed to Design of Experiments (DOE) and statistical methodologies to support design optimization and decision-making.
- Served as co-lead in stage gate reviews and acted as signatory for all relevant PDP documentation, ensuring traceability and alignment with PLCP and Design Assurance SOPs .
- Managed document control and version management using electronic systems to maintain compliance and audit readiness.
- Partnered closely with Regulatory Affairs to ensure project deliverables met global regulatory requirements and supported market-specific submissions.
- Guided project teams on regulatory and quality compliance , including FDA, EU MDR , and ISO 13485 standards.
- Authored and maintained key quality deliverables such as Risk Management Plan, Design & Development Plan, CAPAs , and Field Assessment Plans .
- Co-led CAPA investigations using tools such as 5 Whys , Fishbone Diagrams , and Six Sigma to systematically resolve quality issues and prevent recurrence.
- Developed and implemented a standardized risk table template for custom implants, resulting in a 60% reduction in turnaround time as part of a continuous improvement initiative
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Senior Engineer
Stryker
04.2021 - 06.2023
- Provided comprehensive support to international markets including EU, Australia, New Zealand, Japan, UAE, and Canada , ensuring timely delivery of customized orthopedic surgical instruments in alignment with clinical and regulatory requirements.
- Delivered innovative and tailored instrumentation solutions for orthopedic surgeries by collaborating closely with global sales teams and surgeons to meet procedure-specific needs.
- Coordinated with external vendor partners to develop and procure prototypes , enabling effective testing in cadaver labs and facilitating early-stage product evaluation.
- Participated in risk management activities for both new product development and legacy products in accordance with ISO 14971 , ensuring patient safety and product effectiveness through comprehensive hazard analysis and risk control strategies.
- Executed usability engineering activities in compliance with ISO 62366-1 , including task analysis, formative and summative evaluations , and developed complete usability files to support regulatory submissions .
- Designed mechanical components and assemblies for orthopedic implant systems, utilizing CAD software and collaborating with cross-functional teams to ensure design intent and manufacturability.
- Supported design verification and validation (V&V) processes, including usability testing , ensuring compliance with internal quality systems and international regulatory standards.
Mechanical Design Engineer
Stryker
03.2019 - 03.2021
- Developed comprehensive technical specifications that clearly outlined design requirements for vendors and manufacturing partners alike.
- Performed analysis on technical designs and prototypes in development stage.
- Implemented advanced simulation tools to accurately predict system behavior under various operating conditions, minimizing the need for physical prototyping iterations.
- Created parts for machining, sheet metal fabrication, and injection molding.
- Led technical planning and tracking for mechanical R&D projects, developing comprehensive Gantt charts and project schedules to map key milestones, dependencies, resource allocation, and deliverables across cross-functional teams.
- Collaborated with Project Management Office (PMO) to align engineering objectives with overarching project timelines, proactively adjusting designs and strategies to mitigate technical risks and avoid delays.
- Drove resolution of complex technical challenges using structured methodologies such as Root Cause Analysis (RCA) , Failure Mode and Effects Analysis (FMEA) , and reliability engineering principles to remove bottlenecks and enhance product robustness.
- Contributed to risk management activities by identifying, assessing, and documenting technical risks , and implementing engineering-driven mitigation strategies in accordance with ISO 14971 standards.
- Ensured Design History Files (DHF) and Technical Files were current, audit-ready, and compliant with FDA 21 CFR 820 and EU MDR requirements for orthopedic Class II and Class III devices.
- Supported smooth design transfer to manufacturing and regulatory affairs teams, including documentation and testing for successful 510(k) submissions of custom surgical instruments and implant systems.
Design Engineer
Stryker
01.2019 - 03.2020
- Led packaging design, verification, and validation (V&V) activities under the New Product Development Process (NPDP) for Spine additive-manufactured implants , ensuring compliance with ISO 11607 , ASTM , and company packaging standards .
- Utilized advanced CAD software (e.g., SolidWorks, Creo) to develop detailed engineering drawings , 3D models , and technical documentation for complex mechanical components and packaging systems.
- Proactively resolved technical issues throughout the product development lifecycle, leveraging strong analytical and problem-solving skills to enhance design robustness and accelerate development timelines.
- Adapted packaging and product designs to align with evolving market requirements , technological innovations, and regulatory expectations , ensuring continued product competitiveness and global readiness.
- Directed iterative design and development cycles , incorporating feedback from prototype testing , manufacturing teams , and clinical end-users to drive continuous improvement and design for manufacturability (DFM) .
Design Engineer
Stryker
08.2016 - 12.2018
- Performed detailed segmentation of lower limb anatomy (Hip, Knee, Ankle) using CT and MRI scan data in Materialise Mimics , enabling accurate 3D reconstruction for patient-specific implant (PSI) design.
- Executed cut planning and design of patient-specific surgical blocks based on surgeon-provided preoperative input, ensuring procedural accuracy and customization.
- Utilized Materialise Magics to design and refine PSI guides , ensuring optimal fit, alignment, and anatomical conformity for individualized surgical applications.
- Conducted implant sizing prediction and analysis , contributing to surgical precision and reducing intraoperative variability.
Intern
ABOVE Solutions
04.2015 - 07.2015
- Developed signal processing algorithms in MATLAB to extract vital physiological parameters for stress analysis using multi-modal biosignals, including Photoplethysmogram (PPG), voice signal, and Galvanic Skin Response (GSR).
- Analyzed problems and worked with teams to develop solutions.
Sales Cum Service Engineer
AKAS Medical
02.2012 - 11.2013
- Managed sales, marketing, and service operations for ICU medical devices , including infusion pumps, syringe pumps, multi-parameter patient monitors , and ECG machines , ensuring alignment with hospital procurement and clinical needs.
- Performed onsite installation, configuration, and validation of critical care equipment, providing technical support and hands-on training to healthcare professionals and biomedical engineering teams.
- Delivered customer-facing technical service and troubleshooting , contributing to high customer satisfaction and fostering long-term client relationships in high-acuity clinical environments.
- Developed early hands-on experience with infusion and monitoring technologies , gaining foundational expertise in medical device functionality, service protocols , and clinical application support .
Education
Master of Technology - Biomedical Engineering
IIT Madras
Chennai06-2016
Bachelor of Engineering - Biomedical Engineering
SGSITS
Indore06-2011
Skills
- New Product Development (NPDP)
- Project Management
- Decision-making capacity
- Project lifecycle expertise
- Process improvement strategies
- Proficient in plastic design, sheet metal, casting, and machined components design
- Custom Orthopedic Implant Design
- Specialty Instrument Design
- Patient-specific instrument design
- DHF documentation, DMR, Regulatory compliance (FDA, IEC 60601)
- Design Failure Mode and Effect Analysis
- Design for Manufacturing (DFM) / DFA / Tolerance Stack-up / GD&T
- Mechanical Risk Management (ISO 14971)
- Design Verification & Validation
- EUMDR
- Usability Engineering
- Design Procedure of Medical Device
- NC CAPA
- Change Management process in Windchill / EPDM
- Cross-functional Collaboration & Manufacturing Transfer
- FEA Tools: SolidWorks Simulation, Abaqus (Linear/Nonlinear)
- Experience with 3D printing
- Pro-E / Creo/ Solid works/ UG/NX10
- Mimics
- Materialise Magics
- MATLAB
- Haptics Engineering
Accomplishments
- ASME GDTP Certified – Technologist Level (Y14.5:2009): Specialized in Geometric Dimensioning & Tolerancing (GD&T) and tolerance stack-up analysis .
- Lean Six Sigma Green Belt (LSSGB): Led process improvement project focused on change management at Stanmore, achieving a 16% efficiency gain (July 2019 – March 2020).
- Leadership Development Program – Stryker Virtual Development Academy (2021): Focused on cross-functional leadership, innovation, and stakeholder engagement.
- Published Research: Breath Rate Variability: A Novel Measure to Study the Meditation Effects, R. Soni and M. Manivannan, International Journal of Yoga (IJOY) , Vol. 12, 2019.
- Provisional Patent Filed (US): Novel process for well-fixed femoral stem extraction , validated through cadaver studies .
Additional Information
- Led EUMDR Remediation Project: Successfully completed regulatory compliance activities for 400+ SKUs in collaboration with cross-functional teams, meeting all deadlines.
- Team Management: Supervised and mentored a team of 5 engineers , driving accountability and performance across multiple product portfolios.
- CSR Leadership: Spearheaded Corporate Social Responsibility (CSR) initiative supporting an NGO for visually impaired children .
- Knowledge Sharing & Capability Building:
Conducted sessions on clinical insights , competitive intelligence , and surgeon feedback to enhance team product knowledge.
Initiated team participation in medical conferences to gather end-user feedback and understand surgical challenges for product design alignment.
Established and led internal GD&T forum to strengthen team competencies in tolerance analysis and design for manufacturability (DFM) .
Championed process improvements by standardizing custom implant risk tables , reducing turnaround time by 60% through template-based documentation.
Timeline
Staff Engineer
Shalby Advanced Technology
08.2024 - 03.2025
Senior Engineer
Stryker
07.2023 - 08.2024
Senior Engineer
Stryker
04.2021 - 06.2023
Mechanical Design Engineer
Stryker
03.2019 - 03.2021
Design Engineer
Stryker
01.2019 - 03.2020
Design Engineer
Stryker
08.2016 - 12.2018
Intern
ABOVE Solutions
04.2015 - 07.2015
Sales Cum Service Engineer
AKAS Medical
02.2012 - 11.2013
Master of Technology - Biomedical Engineering
IIT Madras
Bachelor of Engineering - Biomedical Engineering
SGSITS
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