Derek Pfeffer

DPE was founded in 2017 to provide contract services to start-up medical device companies. What started as nights and weekends grew into a full-time focus. To date under the DPE label have contributed major functional content in devices: HI/HF Ultrasound Cancer treatment, Intravenous Ultrasound, Cystic fibrosis vest and generator, Lithotripsy generator, Cold Storage transport, Male Tumescence Wearable, Pulse Oximeter for diabetic centric use, Full Body scanner for skin cancer, and an automated medication dispenser.

● Ownership of the Product Development Process and responsible for implementation of improvements and the integration of design services to newly acquired (box build) manufacturing facilities.

● Auditing and reviewing the staff's body or work to evaluate training effectiveness, mentoring, and skill building initiatives in an “always improving” organization.

● Mentoring a newly formed Systems Engineering group.

● Mechanical staffing and work direction

● Authoring preliminary and clinical risk plans and FMEA documents.

● Implementation of a Robotics and Automation group, serving the different facets of the Nortech business, such as box builds, PCBA stuffing, and automatic wire and cable assembly.

● Implementation of rapid prototyping lab and equipment to reduce time to design verification for expeditious time to market.

● Completed internal mentoring program and succession planning under the VP of Operations.

● Attract new business through trade shows and client interviews. To represent as a SME to “close” new prospective clients and projects.

● Planning and bidding highly technical and long duration projects.

Started an LLC to provide product development strategies for primarily medical device companies and a few consumer industry products, while working contract for medical device injection molder.

Company was a start-up firm that developed a cutting edge molecular diagnostic device and process using microfluidics to deal with lab based infectious diseases like Zika to the point-of-care. Responsible for the outlining projects, assigning resources and ensuring project success. Engaged and directed strategic partnerships outside the organization to align with company objectives. Developed the company's product development procedure and managed the design history file. Responsible for vertically integrating the company with tools and procedures to manufacture microfluidic devices using rapid prototyping methods through production. Led strategic teams in developing a QMS for a new organization and determining metrics for continual improvements.

Company develops an innovative and advanced contrast dye injection platform, fractional flow measuring, and intravascular ultrasound technologies for cardiovascular surgery. These devices enhance patient and staff safety, improves efficiency, and reduces operational costs in the lab, hybrid operating room, and radiology suite.

Responsible for the design of the disposable patient kit for the injection system. The kit consists of a 2-piece custom plastic design to selectively introduce high pressure fluids for the procedure. The position requires hands-on interaction with unique parts and medical devices from design concept to production. Heavily involved in DFMEA and PFMEA documentation, voice of the customer, and process/product development.

Worked with internal resources to develop a project plan to transform into project scheduling. Duties include development of prints, parts, and system specifications. Document components' dimensional output from the first article through validation. Assist manufacturing and other groups for product improvement activities and maintain this role through 510k submittal until product release. Cataloged the medical devices' design history and maintained the essential records for full product traceability for many aspects of the entire design for both mechanical and electrical documents. Lead on custom plastic part development.

Mechanical Design Engineer, Medical R&D

Company is a custom developer of precision components for several bio-medical clients. Led designers and direct outside sales staff in the development of multi-piece plastic injection molded parts and assemblies. Assess design specifications and databases provided by customers for manufacturability regarding plastic injection molding. Successfully completed over 200 projects for medium and high-volume devices.

● Lead engineer and point of contact for clients responsible for managing many development projects simultaneously.

● Use my abilities to create ECO controlled drawings that provide proper tolerance, assembly instruction, testing procedures, and in process inspection dimensions for Class I, II, and III medical devices.

● Develop and implement Design for Verification tests based on design intent and function.

● Develop prototypes and finished pieces that are derived from many unique manufacturing processes.

● Participate regularly in DFMEA and PFMEA for risk analysis minimization and mitigation.

Automation Engineer

Co-lead mechanical engineer in the development of a six SCARA, ten station robotic cell, to assemble a very specialized product. Developed and evaluated products utilizing Pro Engineer and SolidWorks CAD software. Acquired many skills for designing specialized and industrial engineered medical parts and assemblies that will be qualified though IQ, OQ, and PQ procedures and documentation.

● Created low-volume assembly fixtures using PLC controls to simulate individual automation cell function and performance. Designed specialized end-effectors and mechanisms to position parts and assemble pieces together with the aid of Pro Engineer CAD software.

● Gained skills programming vision systems for real time monitoring and quality control.

● Conducted computer software verification tests and complete documentation for quality control.

● Creating and managing large scale project scheduling to meet deliverables.