RAMAKRISHNAN HARIHARAN
Etterbeek
Summary
Strategic and detail-oriented Project Manager with 11+ years of experience owning all stages of the lifecycle to deliver projects that exceed expectations on time and on budget. Outstanding organizational, leadership, planning and problem-solving skills. Regulatory submissions and implementations on state of the art medical devices.
Overview
12
12
years of professional experience
1
1
Certification
Work History
MDR Functional Lead - Regulatory PMO
HCL Technologies Belgium Bvba (Baxter R&D Europe)
08.2021 - Current
- Based out at Client Location (Client Site) – Baxter R and D Europe, Belgium Website: www.baxter.com,
- Prioritize CE Marked products by ranking system to organize the line of submission and MDR implementation
- Assist R&D team in preparing MDR checklist for compliance assessment, add regulatory interpretation
- Participate in Joint reviews to review assessment results and ensure alignment with regulation
- Review changes to Label and promotional materials and advise on country related requirements
- Work with business and commercial team to understand the business impact for each product group
- Prepare comprehensive project plan with detailed task and schedules to achieve MDR compliance
- Regular status updates on project performance in senior managers review meeting
- Understand PLM tools and application to maintain documents in electronic database
- Coordinating between the cross functional teams like R&D, Quality, Regulatory, Clinical, Marketing, Supply chain, Manufacturing and global teams for MDR program till implementation
- Proactively identifying project and program risks and collaborate with cross functions to find a mitigations
Technical Lead
HCL Technologies Private Limited
03.2018 - 07.2021
- Part of task force team to define strategy and approach for program execution
- Understand MDR focus and industry standpoint and calibrate execution approach on regulatory front
- Develop checklist, procedural guidelines and acceptance criteria for MDR assessment
- Train team on various aspects of MDR and conduct extensive workshop for skill development
- Recruit and plan resource based on the available skill set to align with business need
- Work with senior leadership team to support business prepositions
- Organize pilot assessment for MDR and participate in technical reviews
- Evaluate business risk and initiate mitigation actions to push products under MDR compliance
- Manage the MDR program from customer end to submit the technical documentation package to the notified body, Coordinating with cross tower stakeholders/SME’s for deficiency addressal and Implementation of MDR products to the appropriate market
Senior Design Engineer
eMKa Technologies private Limited
11.2015 - 02.2018
- Creating conceptual and detail design of various products used in door and railway industry
- Designing and development of various testing machines with suitable actuation's and mechanisms.
- Coordinating on developing RPT samples, Silicon Moulds, Proto samples for new product designs.
- Doing project and product costing in both first principle and detailed method
- Managing Invoices, Proposals and Quotations
- Doing basic design calculations and pneumatic circuits
- Project Management and Vendor Development
- Creating & managing structured process for NPD, NPI, VAVE, Design Automation
- Software Usage: Auto CAD, Solid Works, CATIA.
Design Engineering Coordinator (Engineering Dept.)
Quality Group AS
01.2014 - 10.2015
- Creating the conceptual and detail design of products which are used in offshore oil drilling platforms
- Have done basic design calculations as per design requirements, Checking of EBOM, Engineering Drawings, GD&T.
- Performing Tolerance stack up analysis & Managing DFMEA
- Selection of Standard components according to the requirements
- Validate product designs, identify constraints and provide corrective actions
- Creating Pneumatic circuits & selection of suitable pneumatic elements
- Creating rendered animation of various products by using Solidworks
- Making Engineering quotation for the new products
- Address team member grievances and provide support as needed
- Software Usage: Auto CAD, Solid Works, CATIA V5
Design Assistant (New Product Development)
CRI Pumps Private Limited
05.2011 - 11.2013
- Create conceptual and detail design for submersible Motors and Pumps.
- Design rough casting components and create rough casting drawings and manufacturing drawings with GD&T and tolerance as per fit and functional requirements.
- Creation of EBOM, Assembly drawings and perform Tolerance Stack Up.
- Participate in DFMEA reviews and considering DFM, DFA while designing new products.
- Documentation of new products with assembly sequence, quality control manual, drawings and work instructions etc;.
- Supporting production team in relation for sustaining the product manufacturing.
- Follow up the New product from prototype to first product despatch using Oracle ERP Software.
- Software Usage: Auto CAD, Solid Works, Unigraphics (UG-NX)
Education
MBA - Operations Management
Periyar University
Salem, India08.2023
Bachelor of Engineering - Mechanical Engineering
Anna University
Nagercoil, India2011
Skills
- Medical Device Project and Program Management
- Medical devices design control documents, DHF Remediation, EU MDR Submissions and implementations, Geo Expansion, ISO 13485, ISO 14971
- Testing machines and New products design and development Engineering Drawings, GD&T and Tolerance Stack
- Problem Solving, Leadership and Team Management
- CAD/CAM Software: AutoCAD, Solid works, UG - NX 75, CATIA V5, Pro-E
- Other Software: Microsoft Office Suite, Oracle, MPP, MS Visio, Trackwise 8, Teamcenter Unified
Accomplishments
- Completed MDR submission and implementation for a Class III medical device
- Completed MDR submissions and Managing DOC sign off for 10+ Class IIb medical devices
- Organized business trips within Europe to host and facilitate workshop for MDR
- Consistent best performer with high performance rating and with strong track record
- Guided team and collaboratively worked with cross functional team and subject matter experts to develop and submit a DEHP justification to the notified body
- Managed stock build and ROW approvals during the MDR transition for business continuity
- Implemented innovative and efficient project management strategy to achieve project goals
Certification
- Certified in Medical Device Regulation (MDR)
- Certified Solidworks Professional (CSWP)
- Participated in a training program on NPD Process conducted by TUV Rheinland
Personal Details
- Date of Birth: 29th July 1989
- Nationality: Indian
- Residence: Belgium
- Father’s Name: R.S.Hariharan
- Gender and Marital Status: Male - Married
- Linguistic Proficiency: English (Professional Level), Tamil (Mother Tongue), Malayalam (Speak basics)
- Passport Number : K3472228
- Single Permit Status & Expiry : Belgium work permit valid until 14 Feb 2024 (Organization Specific)
Timeline
MDR Functional Lead - Regulatory PMO
HCL Technologies Belgium Bvba (Baxter R&D Europe)
08.2021 - Current
Technical Lead
HCL Technologies Private Limited
03.2018 - 07.2021
Senior Design Engineer
eMKa Technologies private Limited
11.2015 - 02.2018
Design Engineering Coordinator (Engineering Dept.)
Quality Group AS
01.2014 - 10.2015
Design Assistant (New Product Development)
CRI Pumps Private Limited
05.2011 - 11.2013
MBA - Operations Management
Periyar University
Bachelor of Engineering - Mechanical Engineering
Anna University
- Certified in Medical Device Regulation (MDR)
- Certified Solidworks Professional (CSWP)
- Participated in a training program on NPD Process conducted by TUV Rheinland
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