Summary
Overview
Work History
Education
Skills
Certification
Languages
Timeline
Generic
Suraj Sur

Suraj Sur

Dubendorf

Summary

Seasoned Sr. Project Manager with a proven track record at Capgemini, adept in leading cross-functional teams to innovate and develop cutting-edge medical devices and software solutions. Expertise in SDLC, QMS audits, and regulatory compliance (ISO 13485, FDA) blends with strong leadership skills to exceed project delivery expectations by optimizing resources and budget management.

Overview

25
25
years of professional experience
1
1
Certification

Work History

Sr. Project Manager

Capgemini
Zurich
09.2022 - Current
  • Company Overview: Capgemini is a global leader in consulting, digital transformation, technology, and engineering services
  • Client: Sonova: Technical Adviser: Market assessment, Competitive advantage and creating roadmap and timeline for Connectivity/ BLE Audio (Classic + Auracast) development
  • Client: Novartis: Sr
  • Consultant and Technical Adviser for SaMD development for new ways of treatment Ophthalmology patients (precise imaging device)
  • Client: SHL Medical: Product Manager: Auto-injectable medical and cloud connectivity for patient motoring
  • Client: SHL Medical: Sr
  • Consultant and Product Manager: Competitive advantage, Master schedule, Roadmap and Quality assessment for introducing AI/ML in medical device production
  • Client: Roche Diagnostics: Sr
  • Consultant and Product Manager: Competitive advantage, market assessment for introducing AI/ML in development of medical device (IVDR) and patient treatment
  • Responsibilities: Leading innovative in new product development with several prestigious clients, Driving innovation in addressing customer needs, Advising and managing multiple digital solutions, Leading the product development teams Software, QA, RA, HFE (India, Ukraine and USA), Strong understanding with FDA and MDR processes, Creating product features, project master schedule, milestones, Scheduling workshop with all stakeholders for demos, resolving technical issues and risk mitigations, Presenting bi-weekly status to head of the sponsorer & Capgemini on projects progress, risks, spending, resource needs, budget status and milestones, Liaison between cross functional teams R&D, Quality affairs, Regulatory affairs, Commercial, Clinical
  • Capgemini is a global leader in consulting, digital transformation, technology, and engineering services
  • Tools – Methodology: MS Project, MS office, Atlassian tools: Jira, Confluence, Polarion, SAFe Agile Methodology, AWS, Dev Ops, Cybersecurity, IEC 62304, ISO 13485, ISO 14971, IEC 62366-1, IEC 82304, 21 CFR 820, FDA, MDD

Associate Project Director, Connected Health

Novartis
Basel
01.2022 - 09.2022
  • Company Overview: Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide
  • Project: Intelligent Precision of Disease Assessment (IPDA), new product development of AI/ML based novel SaMD (Software as Medical Device), clinical decision support medical device for Ophthalmologist for efficient treating of anti-VEGF patients
  • Responsibilities: Driving the innovation for next generation SaMD product development in collaboration Novartis Ophthalmology R&D in collaboration with The Alan Turing Institute, UK and The McGill University, Canada, Managing project (budget 2.3M USD) and creating master plan, milestone, delivery, Leading the teams: Software, QA, RA, HFE, Managing external vendors (Zuhlke and RetinAI) and internal teams, Presenting bi-weekly status to head of the department on project status, and milestones, Managing partnership relation with Heidelberg, Zeiss, Topcon for innovation and product development, Scheduling workshop with all stakeholders for resolving technical issues, compression exercises, process gates and risk mitigations
  • Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide
  • Tools – Methodology: MS Project, MS office, Atlassian tools: Jira, Confluence, Polarion, SAFe Agile Methodology, AWS, Cybersecurity, IEC 62304, ISO 13485, ISO 14971, IEC 62366-1, IEC 82304, FDA, MDD

Sr. Project Manager, R&D

Medmix Ag
Zurich
08.2021 - 12.2021
  • Company Overview: Medmix is a global leader in the development and manufacturing of precision dispensing solutions
  • Project: D-Flex ecosystem, Pen (Medical device), SaMD platform for subcutaneous injectable device
  • Bridging the gap between fixed and variable-dose pens, to paves the way for connected commercial devices
  • Responsibilities: Creating product features, project master plan, schedule, milestones for SaMD and Medical device development, Leading the teams: Electronics, Software, HFE, Weekly status update to head of the department on project status, Liaison between cross functional teams Quality affairs, Regulatory affairs, Commercial, Clinical and marketing, Owner of DHF
  • Medmix is a global leader in the development and manufacturing of precision dispensing solutions
  • Tools – Methodology: MS Project, MS office, Atlassian tools: Jira, Confluence, Aligned Elements (ALM), SAFe Agile Methodology, AWS, Dev Ops, Cybersecurity, iOS and Android, IEC 62304, ISO 13485, ISO 14971, IEC 62366-1, IEC 82304, FDA, MDD

Sr. Product Manager, R&D

Aidian Oy (Orion Diagnostica Oy)
05.2018 - 08.2021
  • Company Overview: Aidian is a leading provider of point-of-care testing solutions
  • Project: Hba1C for QuikRead go IVD device (Class – IIa): development of Hba1C analytes software in the portfolio of analytes
  • “Aidian Connect“ (Class – IIa): Android and iOS, AI/ML based novel SaMD, for clinical decision support tool for HCPs for efficient treating of patients and early detection of diabetics
  • Accepting patients data and quality control results from QuikRead go
  • Responsibilities: Driving innovation for new analytes, Hba1C development (SW development and HW upgrades) to existing IVDR device (QuikRead Go), New SaMD product development for new ways of patient treatment, Managing the product development teams of portfolio of medical device, analytes, SaMD under design control, Managing the product life cycle management teams (software, mechanical, electrical), Product owner of multiple projects, Creating product features, reviewing milestones, accepting deliverables, Managed project budget 1.7M Euro (Aidian Connect, SaMD) and 4.7M USD (QuikRead Go), Presenting bi-weekly to CTO on project progress, risks, resource needs, budget status and milestones, Managing partnership relation with other medical OEMs, Liaison between cross functional teams Quality affairs, Regulatory affairs, Commercial, Clinical and marketing, Participation in Notified body audits, Owner of DHF
  • Aidian is a leading provider of point-of-care testing solutions
  • Tools – Methodology: Jira, Microfocus Caliber (SW reqs), Codebeamer, NoMagic (SysML), M-files (DHF), Git, MS Office, MS project, SAFe Agile Methodology, AWS, Dev Ops, Cybersecurity, Ionic (cross platform development, iOS and Android), IEC 62304, ISO 13485, ISO 14971, IEC 62366-1, IEC 82304, IVDR

Sr. Project Manager, R&D

Dexis Oy (Envista Inc.)
Finland
10.2013 - 05.2018
  • Company Overview: Dexis is a leading provider of dental imaging solutions
  • Project: OP3D (Class – IIb): development of innovative Low Dose Technology for CBCT extra oral 3D X-ray imaging medical device
  • OP3D-Pro (Class – IIb): maintenance and product life cycle management of Low Dose Technology and large FOV, CBCT extra oral 3D X-ray imaging medical device
  • Responsibilities: Driving innovation in new product development, OP-3D, low dose 3D dental X-ray device, Introducing new SW platform (Unbuntu, freeRTOS, Java based GUI), new HW platform (STM32 ARM Cortex MCU, Altera -V), Creating new product features and managing from feasibility to design transfer to production, Liaison between the product life cycle management teams, Product owner, Creating master plan, milestones, accepting deliverables, Liaison between cross functional teams Quality affairs, Regulatory affairs, Commercial, Clinical and marketing, Participation in Notified body audits, Owner of DHF
  • Dexis is a leading provider of dental imaging solutions
  • Tools - Methodology: Jira, Microfocus Caliber (SW reqs), Codebeamer, Polarion, Git, MS Office, SAFe Agile Methodology, Dev Ops, IEC 62304, ISO 13485, ISO 14971, IEC 62366-1, IEC 62304, FDA

Managing Director (Co-founder)

Cognizantit Oy
Finland
03.2012 - 10.2013
  • Company Overview: Cognizant is a leading provider of information technology, consulting, and business process services
  • Project: Development of firmware and software of PDA, mobile computer for demanding military and government use
  • Responsibilities: Software architect, software development, device drivers, verification and validation, Managing the product development team
  • Cognizant is a leading provider of information technology, consulting, and business process services
  • Tools - Methodology: Jira, Git, C, C++, Linux

Global Software Project Manager, R&D

Nokia Oy
Finland
12.2008 - 03.2012
  • Company Overview: Nokia is a global leader in technologies that connect people and things
  • Project: USB (2.0, OTG) drivers for portfolio of Nokia handsets for Symbian and Linux, Linux based application for new devices
  • Responsibilities: Project management, product owner, Software architect, Global customer support
  • Nokia is a global leader in technologies that connect people and things

Team Leader, R&D

Samsung Inc.
S. Korea & India
05.2005 - 12.2008
  • Company Overview: Samsung is a global leader in technology and consumer electronics
  • Project: Firmware and software development for Samsung high end multimedia handsets
  • Responsibilities: Project management, product feature development, Product development, software architect, software development, Global product support
  • Samsung is a global leader in technology and consumer electronics

Team Leader, R&D

ST Microelectronics
Italy & India
05.2000 - 05.2005
  • Company Overview: STMicroelectronics is a global semiconductor leader delivering intelligent and energy-efficient products
  • Project: Nomadik: Firmware development for multimedia mobile phone chipsets (STN 8800, 8810, 8815)
  • Responsibilities: Project management, product feature development, Product development, software architect, software development, Global product support
  • STMicroelectronics is a global semiconductor leader delivering intelligent and energy-efficient products

Education

MBA -

Helsinki School of Economics
Finland
01.2011

B. Tech - Computer Engineering

India
01.2000

Skills

  • Product development
  • Technology
  • Software development
  • Planning
  • Risk
  • Scope
  • Delivery
  • Budget
  • SDLC
  • Technical Manager
  • Team leading
  • SaMD
  • Medical device development
  • Highly precise electromechanical medical device development
  • SME for QMS
  • QMS audit
  • ISO 13485
  • IEC 62304
  • ISO 14971
  • IEC 62366-1
  • IEC 82304
  • IEC 60601-1
  • 21 CFR 820
  • FDA
  • MDR

Certification

  • Certification, Scrum, 2014
  • Certification, SaFe, 2018
  • Training, GMP, QA, RA, 2022
  • Training, MIT AI in Health Care, 2023
  • Training, PMI, 2007

Languages

  • English, Fluent
  • Finnish, Basics

Timeline

Sr. Project Manager

Capgemini
09.2022 - Current

Associate Project Director, Connected Health

Novartis
01.2022 - 09.2022

Sr. Project Manager, R&D

Medmix Ag
08.2021 - 12.2021

Sr. Product Manager, R&D

Aidian Oy (Orion Diagnostica Oy)
05.2018 - 08.2021

Sr. Project Manager, R&D

Dexis Oy (Envista Inc.)
10.2013 - 05.2018

Managing Director (Co-founder)

Cognizantit Oy
03.2012 - 10.2013

Global Software Project Manager, R&D

Nokia Oy
12.2008 - 03.2012

Team Leader, R&D

Samsung Inc.
05.2005 - 12.2008

Team Leader, R&D

ST Microelectronics
05.2000 - 05.2005

MBA -

Helsinki School of Economics

B. Tech - Computer Engineering

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