MDR Program Manager
Overall Responsibilities:
The Program Manager (PM) will prepare execution strategies and project plans for the implementation of the MDR within Trauma, CMF, Bio-Materials and Spine Business Units and coordinate the alignment and execution of all activities related building the new Technical Documentation and obtaining CE marking in compliance with EU MDR. With expertise in Program Management, this individual will proactively coordinate cross-functional deliverables from R&D, Regulatory, Medical Affairs, Quality, Biocompatibility, Labeling and any other functions as needed to deliver the new Technical Documentation and apply for CE Marking. Work together with EU and US Manufacturing Site Managers and 3rd party suppliers on cross-site leveraging, best practice sharing and effective planning and deployment of corporate, MDR and Global Orthopedic Initiatives across all Customer manufacturing sites in DACH region to Ensure cross-functional alignment of goals, strategic initiatives and projects to meet our manufacturing vision 2020 - Planning of manufacturing goals and strategies to be deployed - Ensure Major cross-functional issues and conflicts addressed and resolved - Review and align regional projects and priorities to ensure consistency in execution - Accelerate implementation/execution of strategic initiatives across Customer EMEA supply chain The MDR PM is a critical position responsible for planning and execution of all activities associated with Product and documentation readiness activities for Product Registration within the Orthopedic/ pharmaceutical Business Unit in the region of Solothurn and Basal as part of the wider companywide Implementation of the MDR. The new PM will provide significant cross functional co-ordination and accurate execution of a multi-year multi-million-dollar program to ensure products are maintained on the market providing life sustaining performance. In all actions, the PM must demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policies and all other documented quality processes
Position duties and responsibilities
  • Drive project planning & management reviews to meet EU MDR/IVDR timelines and budget requirements, directing resources to realize milestones and Key Performance Indicators (KPI’s) utilizing problem solving tools and/or lean tools and methodologies. Design & implement central project management tools/templates (SharePoint, trackers, etc.,), support lessons learned driving consistency and alignment across businesses, workstreams and taskforces with peers.
  • Support the EU MDR/IVDR Program Management Organization (PMO) leader, defining process improvements, ways of working & interfaces with businesses and other functions developing timelines, deliverables and ensuring there will not be fundamental strategic and operational disconnects between the cross-enterprise framework and business entities (including pre-market, supply chain/operations, post market and IT functions).
  • Strong analytical, planning, organization and time management skills to effectively develop and execute comprehensive programs and budgets. Ability to plan and manage larger team and handle escalations. Develop plans using goals and objectives of the project, appropriate related procedures, applicable historical information, and other necessary resources to align projects with the expectations of sponsors and stakeholders.
  • Support internal program and external communication, which includes content and planning for communications cascades, and supporting review / feedback. Identify key requirements needed from cross-functional teams and external vendors
  • Being responsible for establishing the relations with Customer and Customer Leadership and Effective decision-making skills with ability to negotiate and balance decisions and priorities across needs of several functional departments and willingness to make tough decisions
  • Ensure product is meeting the latest standard requirements, perform re-testing to improve the quality and fixing the issues with respect to design and functionality and intended use of the devices.
  • Responsible and has vast experience in Design and Clinical Risk Management, Production Risk Management, Post Market Surveillance, Biological Safety Evaluations, Clinical Evaluation, Assessment of Manufacturing Process Information, Impact Assessment of Current Standards and Applied Standards
  • Provide Support for design compliance to comply medical device standards such as ISO 13485, ISO 14971, IEC 60601-1, ISO 11607-1 &2
  • Business acumen; ability to think and act from an overall “best for the business” perspective
  • Change agent -- willingness and ability to lead and institute change
  • Work with other PMs to identify risks and opportunities across multiple projects within the department
  • Address new clinical data requirements under MDR and IVDR
  • Develop a global market entry strategy to capitalize on opportunities
  • Consider launching new products in the US and other countries
  • Manage larger team in onsite/offshore team and improve the efficiency in the system
Skills Profile
  • Expertise in New Product Development and Sustaining Engineering Services and ability to demonstrate in Patient Safety and Product Life Cycle management
  • Good experience in Regulatory (DHF, TechFile & China TRD Remediation) and compliance projects.
  • Working knowledge in medical device standards, FDA guidance, European regulations etc.,
  • Prior working experience in an FDA regulated environment and Quality Systems Regulations with knowledge in documentation systems (i.e., Verification & Validation Protocols, SOPs)
  • Exceptional leadership, time management, facilitation, and organizational skills
  • Dynamic problem solver able to anticipate potential problems and create solutions.
  • Ability to run meetings and workshops (face to face, conference call, Global Connect).
  • Hands on experience in Creo Platform and Intrinsic knowledge in Adaptiv, Windchill/Agile PLMs
  • Good Experience in MQMS process
  • Knowledge in Statistical Data Analysis using Minitab and Knowledge in GD&T and Tolerance Stack-up Analysis (2D/3D using VIS-VSA and Sigmund works)
  • Standards Policy Shaping Perform Gap Analysis and ability to Rationalize the identified gaps
  • Outstanding working knowledge of change management principles and performance evaluation processes and Stakeholder management skills
Qualificiations
  • 15+ years of experience in product design and minimum of 10 years in Medical Devices
  • Bachelor’s degree in Mechanical Engineering and minimum 7 years of program/project and/or engineering experience or minimum 5 years of program/project experience and/or engineering
Interpersonal skills / characteristics (if applicable)
  • Very Strong communication skills, oral and in writing
  • Strong Conceptual Thinker and Tactical
  • Strong Analytical Skills / Strong Capabilities and holistic thinking
  • A demonstrated ability to influence cross-functional Management, strong interpersonal skills
  • Proven proposal writing experience
  • Excellent presentation skills
Minimum Language required
  • German - Basic for German speaking sites
  • English & Tamil- Very good
If you are interested, please send your application via mail to Mr Aman Dhall: aman.dhall@hcl.com

Only applications via Mail in PDF format will be accepted.