About

Dirk Schipper
Product Development & Project Management
For Medical Device Start-Up Companies

Dirk is a graduate of Western Michigan University in Kalamazoo, MI where he earned his B.S. in Industrial Engineering and MBA in Management. He is a member of the Project Management Institute, the Institute of Industrial Engineers, and Council of Supply Chain Management Professionals

Dirk Schipper has thirty eight years of experience with pharmaceutical and medical device start-up companies, working as product development engineer, supply chain manager, business process reengineering consultant, internal consultant with a Fortune 100 Company, new product introduction project manager, line manager, and Industrial Engineer. These have resulted in the ability to successfully develop and launch new products for pharmaceutical and medical device start-up companies and at the same time manage complex, global projects through matrix, virtual, and multi-cultural project teams.

Core strengths that Dirk brings to Medical Device start-up companies are:

Product Development — work within medical device start-up companies to develop critical success factors, product requirements, interface with engineering development companies, ensure completion of all aspects of the engineering process, including design input/output matrix, Failure Modes Effects Analysis (Design and Process), biocompatibility, package development, product validation, sterilization validation, accelerated aging, Design History File and Device Master Record.

Project Management — develop and maintain comprehensive project plan for entire management team, including milestones required to secure future tranches

Marketing Support — develop prototypes and work with marketing companies to conduct focus group studies

Regulatory & QMS Support — prepare 510(k) and Tech Files for regulatory submissions and approvals, implement Quality Management Systems

Supply Chain Management — support market launches of new medical devices, managing all aspects of the supply chain


Warren Lun
Product Development & Project Management
For Medical Device Start-Up Companies

Warren is a graduate of Western Michigan University in Kalamazoo, MI where he earned his B.S. in Industrial Education and Master’s in Library Science, majoring in Information Science.

Warren Lun has over twenty-five years of experience working in medical device companies, employed as a senior development engineer, product development engineer, manufacturing support engineer, and medical device designer. He has successfully managed, developed and launched numerous Class III and Class II medical devices ranging from brachytherapy seed dispensing, oncology and radiological, cardiovascular, hemodialysis, breast health, gynecological, minimally invasive surgical devices, and orthopedic surgical support instruments. He has been awarded six medical device patents on three of his medical devices.

Core strengths that Warren brings to Medical Device start-up companies are:

Product Development — work within medical device start-up companies to develop critical success factors, product requirements, interface with engineering development companies, ensure completion of all aspects of the engineering process, including design input/output matrix, Failure Modes Effects Analysis (both Design and Process), biocompatibility, material selection, product and process validation, sterilization validation, accelerated aging, Design History File and Device Master Record.

Project Management — develop and maintain comprehensive project plan for entire management team, including milestones required to secure future tranches

Marketing Support — develop prototypes and work with marketing companies to conduct focus group studies

Regulatory & QMS Support — prepare 510(k) and Tech Files for regulatory submissions and approvals, perform Risk Analysis and implement Quality Management Systems

Supply Chain Management — support market launches of new medical devices, managing all aspects of the supply chain

phone: (616) 990-0060          email: dirk.schipper@glexel.com