プロフィール詳細

プロジェクトを作成

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Peter S.に依頼

United States

Experienced Medical Device Program Manager | Mechanical Engineer | Product Development & Regulatory Strategy Expert

プロフィール概要

Senior Program Manager with over 10 years of experience in the medical device industry, specializing in Class III, life-sustaining devices. Proven expertise in cross-functional project leadership, product development, design control, and regulatory compliance. Mechanical engineering background with hands-on design experience, supported by advanced degrees from Boston University and Brown University. Strong track record in managing complex development programs from concept through commercialization, with a focus on quality, risk management, and global regulatory alignment.

専門分野

• ★ Medical Device Design
• ☆ Medical Devices
• ☆ Medical Device Marketing
• ☆ Medical Device Development
• ☆ Biocompatibility Testing
• ☆ Medical Device Manufacturing
• ☆ Medical Device Safety Testing
• ☆ Medical Device Validation
• ☆ Medical Implants
• ☆ Wearable Technology
• ☆ Medical Device Prototyping
• ☆ Innovation Management
• ☆ Management Information Systems
• ☆ Project Management
• ☆ Risk Management
• ☆ Six Sigma

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing, Business & Legal Writing, Copywriting, Creative Writing, Newswriting, Audio Transcription

Research Market Research, User Research, Feasibility Study

Consulting Healthcare Consulting

Product Development Manufacturing, Quality Assurance & Control (QA/QC), Concept Development

職務経験

Sr. Manager

Edwards Lifesciences (United States)

8月 2024 - 現在

Project Manager - Consultant

ICU Medical (United States)

5月 2024 - 8月 2024

Design Engineer

Acumed (United States)

5月 2023 - 5月 2024

Engineering Project Lead

BrioHealth Solutions

5月 2020 - 3月 2024

Design Engineer

Hospital for Special Surgery

3月 2015 - 3月 2020

Summer FEA Intern

Hospital for Special Surgery

6月 2014 - 8月 2014

学歴

Non-Degree (Mechanical Engineering)

Columbia University

9月 2015 - 12月 2015

M.S. in Solid Mechanics (Mechanical Engineering )

Brown University

9月 2013 - 12月 2014

B.S. (Mechanical Engineering)

Boston University

9月 2009 - 5月 2013

認定資格

• Six Sigma Black Belt (CSSBB)

  American Society for Quality

  7月 2019 - 現在

• Certified Quality Engineer

  American Society for Quality

  4月 2019 - 現在

• Project Management Professional

  Project Management Institute

  2月 2019 - 現在

• Certified Reliability Engineer

  American Society for Quality

  3月 2018 - 現在

• Professional Engineer (PE) - Machine Design & Materials

  NCEES

  12月 2019 - 2月 2025