Summary
Overview
Work History
Education
Skills
Certification
Languages
Timeline
Generic

Mikhail Weekes

Boca Raton,FL

Summary

Experienced project manager with global expertise in medical device development and drug delivery systems. Successfully piloted project management initiatives now adopted globally. Skilled in leading cross-functional teams, ensuring regulatory compliance, and aligning projects with strategic goals. Known for mentoring team members, fostering collaboration, and delivering results in fast-paced, regulated environments.

Overview

7
7
years of professional experience
1
1
Certification

Work History

Project Manager

SHL Medical
07.2022 - Current
  • Manage multiple projects simultaneously by prioritizing tasks based on urgency, resource availability, and alignment with organizational goals.
  • Plan medical device development projects in compliance with established Design Controls.
  • Provide regular project updates to stakeholders, highlighting deliverables, required adjustments, and overall progress.
  • Coordinate with cross-functional teams to resolve project issues and mitigate risks.
  • Mentor team members in project management best practices and the PLM system to enhance skills and improve team performance.
  • Successfully piloted new project management initiatives leading implementation across global organization management

Project Manger

Scandinavian Health Limited
08.2018 - 07.2022
  • Lead project communication with the customer and senior management.
  • Monitor project cost, status on payment milestones and ensure any significant changes are reported.
  • Lead design verification/assessment and new test method development, assessment and verification activities.
  • Lead Root Cause Analysis activities around device functional release testing failure modes.
  • Lead cross-functional teams at technical meetings with the customer on risk assessment, product development, and automated assembly machine qualification.
  • Ensure project activities are executed in accordance with our clients agreed upon Direct Input Requirements (DIR), quality agreements and regulatory requirements and ISO guidelines.

Education

MBA - Technology Management

National Tsing Hua University
Hsinchu, Taiwan (ROC)
07-2018

Master of Science - Electrical Engineering

Feng Chia University
Taichung, Taiwan (ROC)
07-2016

Skills

  • Project management
  • Team collaboration
  • Customer relations
  • Stakeholder communications
  • Root-cause analysis

Certification

  • Certified Associate in Project Management, by PMI
  • Introduction to Project Management for Product Development of Medical Devices, by Medical Device HQ
  • Lean Six Sigma Green Belt, by SSGI


Languages

English
Native or Bilingual
Chinese (Mandarin)
Full Professional

Timeline

Project Manager

SHL Medical
07.2022 - Current

Project Manger

Scandinavian Health Limited
08.2018 - 07.2022

MBA - Technology Management

National Tsing Hua University

Master of Science - Electrical Engineering

Feng Chia University

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