Akhilesh Pal

Operations Associate

Pune, Maharashtra, India13 yrs 10 mos experience

Most Likely To Switch

Key Highlights

Certified Scrum Master with 13+ years of experience
Expert in regulatory compliance and risk management
Proven track record in leading global cross-functional teams

Stackforce AI infers this person is a Healthcare and Engineering professional with expertise in product development and regulatory compliance.

Contact

akhilp.iitk@gmail.com LinkedIn

Skills

Core Skills

Global Project CoordinationRegulatory Compliance (fda, Eu Mdr, Mdsap)New Product Development (npd)Orthopaedic Trauma Implant DesignVave (value Analysis & Value Engineering)Cad Modelling & PrototypingAerodynamics Model Design (wind Tunnel Projects)Mentorship & Training Of Engineers

Other Skills

Agile & Scrum (Sprint Planning, Backlog Grooming)Agile MethodologiesAutoCADBOM & Regulatory DocumentationBOM Management & Engineering Change Notices (ECN)CE Marking Process & MDR TransitionCNC Machining & Manufacturing FeasibilityCollaboration with European TeamsComputer-Aided Design (CAD)Creo & SolidWorks Advanced CADCross-functional Team LeadershipDFMEA & Material SelectionDFMEA & Technical File DocumentationDFMEA / PFMEA / Risk ManagementDHF / RMF Gap Analysis & Remediation

About

Certified Scrum Master with 13+ years of experience leading product design, development, and global projects in the medical device, aerospace, and automotive sectors. Proven track record of driving innovation while ensuring regulatory compliance with ISO 13485, ISO 14971, FDA, and EU MDR standards. Expert in risk management methodologies (FMEA, FTA, HACCP), new product development (NPD), and sustaining engineering projects. Adept at leading cross-functional and global teams (30+ members) to deliver high-quality, compliant products on time and within budget. Proficient in CAD (SolidWorks, CATIA, AutoCAD) and PLM systems (Windchill, Teamcenter), with a strong focus on process optimization, design controls, and cost-effective solutions. Passionate about delivering innovative and safe products that improve patient outcomes while achieving business goals.

Experience

13 yrs 10 mos

Total Experience

2 yrs 3 mos

Average Tenure

2 yrs 9 mos

Current Experience

Cyient

Process Specialist onsite at Boston scientific

Sep 2023 – Present · 2 yrs 9 mos · Pune, Maharashtra, India · On-site

Manage multiple portfolio optimization project for Class II & III medical devices, ensuring compliance with ISO 13485, ISO 14971, and FDA QSR.
Conduct DFMEA/PFMEA sessions and risk mitigation strategies across global cross-functional teams.
Lead global meetings with stakeholders in the US, Ireland, UK, Germany, Israel, and India to align project objectives.
Perform DHF/RMF gap assessments and oversee remediation planning.
Develop integrated project schedules, risk registers, KPIs, and dashboards for leadership reporting.
Facilitate Agile/Scrum ceremonies including sprint planning, backlog grooming, and retrospectives.

DFMEA / PFMEA / Risk ManagementGlobal Project CoordinationGlobal Cross-Functional Team LeadershipRegulatory Compliance (FDA, EU MDR, MDSAP)DHF / RMF Gap Analysis & RemediationDesign Controls (ISO 13485)+13

Kaushik orthopaedic pvt ltd

Head of design and development

May 2022 – Aug 2023 · 1 yr 3 mos · Sonipat, Haryana, India

Led NPD projects for trauma implants (Tibia Plates, Femoral Nails, Cannulated Screws) from concept to validation.
Converted surgeon feedback into design inputs and technical specifications.
Conducted design reviews, DFMEA sessions, tolerance stack-ups, and prototype validation.
Prepared DHFs, RMFs, CERs, and MDR submissions for regulatory approvals.
Collaborated with QA/RA for global registrations and IEC 62366-1 usability studies.
Closed NCRs/CAPAs and qualified vendors to ensure product quality and compliance.

BOM Management & Engineering Change Notices (ECN)Global Project CoordinationDFMEA & Material SelectionRegulatory Compliance (FDA, EU MDR, MDSAP)Design Controls & Traceability MatrixNew Product Development (NPD)+27

Mirus™

Sr. Design Engineer

May 2021 – Feb 2022 · 9 mos · Gurugram, Haryana, India · On-site

Designed cervical spine systems and custom implants using SolidWorks; validated designs through DVer/DVal.
Authored technical files, verification protocols, and reports for regulatory submissions.
Led supplier development (DFM/DFT, PPAP) and supported sterilization validation and labelling design.

BOM Management & Engineering Change Notices (ECN)Global Project CoordinationRegulatory Compliance (FDA, EU MDR, MDSAP)Design Controls & Traceability MatrixSterilization Validation & LabellingVAVE (Value Analysis & Value Engineering)+21

Auxein medical

Design and development Head

Jan 2019 – May 2020 · 1 yr 4 mos · Sonipat, Haryana, India · On-site

Directed portfolio of orthopaedic trauma implants from design through CE marking.
Implemented design controls, traceability matrices, and MDR readiness gap analyses.
Supported notified body audits and ensured documentation compliance.

BOM Management & Engineering Change Notices (ECN)Global Project CoordinationRegulatory Compliance (FDA, EU MDR, MDSAP)Design Controls & Traceability MatrixVAVE (Value Analysis & Value Engineering)DHF / RMF Gap Analysis & Remediation+19

Gunnebo australia

CAD Design Engineer

Sep 2017 – Oct 2018 · 1 yr 1 mo · Gurgaon, Haryana, India · On-site

Collaborated with global engineering teams to redesign and optimize cash automation systems (VAVE projects).
Modeled complex parts/assemblies in Creo & SolidWorks; managed BOMs and ECNs.
Led root cause analysis for field failures and coordinated with European clients and vendors for validation.

BOM Management & Engineering Change Notices (ECN)Global Project CoordinationVAVE (Value Analysis & Value Engineering)DVer/DVal (Design Verification & Validation)Creo & SolidWorks Advanced CADPrototype Development & Testing Coordination+6

Indian institute of technology, kanpur

Senior Project Associate

Jan 2011 – Sep 2017 · 6 yrs 8 mos · https://www.iitk.ac.in/nwtf/ · On-site

Designed, manufactured, and assembled wind tunnel models for aerodynamics research (ISRO, HAL, NTPC projects).
Developed complex test rigs and instrumentation; conducted CFD/FEA simulations for optimization.
Mentored junior engineers on CAD modeling, prototyping, and test setup.

BOM Management & Engineering Change Notices (ECN)Global Project CoordinationThermal & Pressure InstrumentationDVer/DVal (Design Verification & Validation)Mentorship & Training of EngineersTest Fixture & Rig Development+7