D r. I r . Robe r t Sp l i n ter, PhD

*** ******** **. ******, ***** Carolina Phone: 1-919-***-**** acgdcs@r.postjobfree.com

OBJECTIVES

KEY SKILLS

• Managed scientific development process and technology transfer. Supervise engineers of diverse

background to work on a structured team effort as well as supervise technician involvement. Assigned and

coordinated tasks throughout a system's entire life cycle and controlled procurement.

• Worked on Class II and Class III medical devices, diagnostics and therapeutic supporting technologies and

development. Worked on Regulatory Affairs issues directly with FDA. Provide technology integration as well as

multifaceted engineering support and innovation.

• Energetic and passionate self-starter and independent worker with management skills geared to the specific

individual’s needs.

• Proficient in all MS-Office utilities (e.g. MS-Word, Excel, PowerPoint, Visio, etc.) as well as Microsoft and

other operating systems. Expert in MS Project.

• Managed clients of diverse background to work on a structured team effort as well as supervise technician

involvement and assignment and coordination of tasks throughout the entire system developmental life cycle.

• Excellent knowledge of Design of Experiment: JMP8, Statistics support, Excel and SAS.

• Skilled in all aspects of sensor design; engineering, biomedical engineering, as well as all aspects of

physics and mathematics. Experienced in Electronics, Image processing, Optics, RF, signal processing and

Ultrasound. Additional experience in drug interaction / biochemistry.

• Fluent in English, Dutch, German, French and intermediate Russian and Bulgarian.

• Group Leader and innovations design. Experienced in MS Project, extensive use of Agile and Oracle.

Technological Summary

Technology Manager and Engineering Leader with more than eighteen years of science and medical device

technology experience using engineering and physics technologies. Perform design and verification. Manage New-

Product introduction. Strengths include cross-functional interaction with clients, and external and internal

departments. Provided key recommendations on selection of business opportunities and appropriate engineering

requirements. Prominent demonstration of successful mentoring and inspiring team members to achieve high-

quality output on timely basis.

Splinter Consultants 2013 - current

Technology Officer: Technology support. Examples of clients :

• Optoniks, NC; New Applications and technology support for product innovation and market launch. Manage

New Product Development and New Product Introduction. Currently engaged, long-term contract.

• Stetter Electronik; Germany. Regulatory support for New Product Development. Currently engaged.

• Spectranetics, CO; New Application and technology support for new device development and introduction,

transcatheter drug introduction. Regulatory Affairs & FDA. Previous client.

Submitted two (2) patent applications on innovative efforts.

Professional Experience

Valencell, Inc.; Raleigh, NC 2011 – 2013

Product Development; Manager Technology and Innovation

In charge of New Product Introduction, supervising research, developing effective consumer devices based on

multifacted and integral based technologies, providing mechanism to yield vital information to customer.

Robert Splinter Page 1 of 3

• Manage point-of-care device development from concept, feasibility, and validation to production. Work closely

with marketing and define the delivery strategies. Plan, execute and supervise laboratory experiments.

Submitted two (2) patent applications.

• Developed and managed in-house teams and outside contracts. Evaluate business opportunities. Provide

cross-functional support.

• Material selection and biocompatibility verification. Support technology licensing and engineering transfer.

Support GMP environment. Support document control and design test strategy.

• Maintain regulatory and ISO compliance as well as enforce standards and quality control.

Spectranetics Corporation; Colorado Springs, CO 2007 – 2010

Technology Development; Principal Scientist.

Managed Technology program, reporting to VP of Development (COO), supervising research, developing effective

medical devices and providing mechanism to yield procedural information to customer.

• Lead therapeutic and diagnostic device development based on a broad range of technology efforts, IDE.

Oversee and manage all phases of New Product Development and New Product Introduction. Results include

six (6) patent applications. Ensured team member development and training. Scope projects and develop

operating budgets.

• Create, validate and produce sensing technology and managed materials validation process. Performed

selection of engineering and sciences to achieve the chemical, physical and clinical resolution as well as

selected construction base materials. Incorporate analysis, design, integration and marker tagging. Transfer to

manufacturing.

• Managed outside contracts, implemented contracts and supervised projects in several countries. Manage

procurement and product launch.

• Managed biological model design and material qualification, drug interaction, pharmaceutical integration.

Organic, polymer and metallics tests and integration for product design.

• Managed groups of technical and operational professionals and outside contractors. Mentor junior and senior

staff.

• Worked with key opinion leaders to interpret and establish product requirements, designed and prototyped

devices per requirements, performed product evaluation. Supported Regulatory Compliance and submitted

reports internally and to FDA. Working within ISO standards: ISO10993; ISO-13485 and more as well as FDA

compliance CFR-21. Worked with UL and TUV on IEC-60601 compliance issues.

Analytica BG Sciences, LTD; Sofia, Bulgaria 2004 – 2006

Co-Founder, VP New Product Development

Managed nationwide efforts, contracts and technical support. Implemented documentation and maintenance plans.

Made recommendations on design and manufacturability.

• Supervised physicists, mechanical engineers, electrical engineers and support staff. Lead technology transfer.

• Designed and manufactured products and services using a broad scale of technological innovations using

biochemistry, electronics and mechanical engineering.

Cannon Research Center; Charlotte, NC 1988 – 2003

Functional Leader, Senior Scientist

Led Biomedical research and product development based on physician requirements.

• Developed sensing and imaging devices and systems using cutting edge engineering concepts, IDE. Managed

research protocol (animal and human trial studies) Results include five (5) device patents. Develop and validate

computer simulations.

• Acted as Team Leader on concept design and device development in neurological applications. Managed

and inspired groups of people with diverse academic and career background: MSc, BA in ME, EE, IT, computer

sciences and non-science degree experienced technician as well as outside contractors.

• Successfully selected and developed appropriate technology to design, test feasibility and produced devices.

Implemented device master records file system and design and device history filing procedures.

• Managed large-scale projects with subcontractor support. Controlled inventory management system.

Robert Splinter Page 2 of 3

• Developed and implemented QA methodology and provide project reports and made recommendation on path

forward

Education

• Ph. D., Medicine and Engineering; VU University of Amsterdam, The Netherlands

• MSc., Engineering Physics; TU/e Eindhoven University of Technology, The Netherlands

Robert Splinter Page 3 of 3

Contact this candidate