ENGINEERING MANAGMENT

Sr. Program Manager. 20+ yrs in medical device, telemetry and navigation. Bench top trouble shooting to system design. Electrical design, embedded software, requirements, project startup. BSEE, Minor Biochemistry.

Sr. Program Manager. 20+ yrs in medical device, aerospace, sports and commercial. Design to Exec. Mgmt. Mechanical design, process design, intellectual property, problem resolution. MSME, BSME, Minor Economics and Computer Science Engineering.

MECHANICAL ENGINEERING:
Mechanical Engineer. 20+ yrs manufacturing engineering and medical equipment. Custom automated systems. Expertise in parametric modeling, Solidworks. Plastics & Sheet Metal. MSME.

Sr Mechanical Engineer. 20+ yrs designing products in medical and aerospace using Solidworks. Interface with software & electronics. COSMOS, stress/strain, plastics, cast metals, sheet metal. BSME.

Sr Mechanical Engineer. 20+ yrs designing products in telecomm and high tech. Sheet metal, plastic injection, tooling. Thermal design and Finite Element Modeling. MSME, BSME.

Sr Design Engineer. 30+ yrs creating new electromechanical products for various markets. Hands on design and prototype fabrication. ME, AE, AAS.

Sr Mechanical Engineer. 20+ yrs designing commercial products in the home appliance and print industries. Mechanisms, packaging, and international project management. BSME.

Mechanical / Aeronautical Engineer. 5+ yrs designing medical, aeronautical, and consumer products. Composites and plastic injection molding. Solidworks, Xfoil, C++, Photoshop, Illustrator. MSAE, BSME/AE.

Mechanical Designer. 25+ yrs creating product solid models in the medical device, diagnostic, and therapy markets. Plastic molding, die casting, sheet metal, rapid prototyping, and assembly. AS Design.

ELECTRICAL ENGINEERING:
Analog/Digital Electrical Engineer. 30+ years developing analog and digital electronics. Sensor conditioning, filters, signal processing, high speed digital, and uC-based digital.

Senior Electrical Engineer. 20+ yrs electrical design of systems for aerospace, fiber optics, and communications. Educator and expert at VHDL for FPGA and CPLD and micro design. MSEE, BSEE.

RF Electrical Engineer. 25+ years developing RF electronics. RF Generators, RF ablation and electrocautery, other specialized medical RF applications. RF system design, analog and uC control.

Sr Engineering Technician. 15+ yrs in calibration and validation in Biotech and Medical Device. Program development and execution for cGMP, FDA and Quality. US Army Electronics School.

SOFTWARE ENGINEERING:
Embedded Software Engineer. 30+ years developing real-time embedded software for medical, military and consumer products. RTOS, GUI, C, C++, C#, SW V&V.

Windows Software Engineer. 20+ years developing Windows-based applications for medical, military and commercial products. Windows, WinCE, Linux, C, C++ and C#, MFC and .NET.

CLINICAL, REGULATORY AND QUALITY:
Regulatory Affairs and Quality Systems. 18+ yrs in medical device, pharma, and biotech. Authors FDA 510(k)s, IDEs, INDs, & NDAs for US & ISO.  BS Psychology / Neuropharmacology, MS Regulatory Affairs, SDSU Adjunct Faculty.

Sr. Quality Engineer. 20+ yrs setting up quality systems, leading teams, training. Sr member ASQ, Registered to Audit to ISO 9001, TL 9000, ISO 14001, Certified EMS & QMS auditor. BSCS

INTELLECTUAL PROPERTY:
Patent Agent. 20+ yrs drafting patents in the high tech arena. IP strategies, portfolio analysis, harvesting, technology innovation, landscapes, valuation, licensing. MS Physics, BS Engineering.

Patent Attorney. Advancing Biotech, Pharma & Medical Device start-ups. Patent & trademark prosecution & incorporations. Clinical, quality, & regulatory for US / Internat'l approval. BS Bio, JD.

General Patent Counsel. Network of 5 major patent law firms on both US coasts that provide patent prosecution, litigation, and due diligence.

INDUSTRIES WE SERVE

Product Development Systems is built on in-depth experience within manufacturing companies covering a broad range of sectors, including:

LEADERSHIP

Mr. DeKalb has over 24 years of experience developing products for individual investors to Fortune 100 companies holding positions from design engineer to the Senior Executive level.

» READ FULL BIO

QUOTES