PROFESSIONAL SUMMARY 

Knowledge-Driven Engineering Executive with success in developing cross-functional engineering teams to reliably deliver working designs before major capital investments are made.

  • A proponent of data-driven design: applying known laws of physics and engineering to product development; utilizing analysis, modeling and simulation in formative design followed with direct-testing at the sub-system level to prequalify functional design; resulting in more reliable, well-characterized products with predictable success: an increased certainty of performance, robustness, and schedule-of-delivery. 

  • A proponent of active client engagement — understanding and delivering to my clients' core values. 

  • A master and lifelong student of technologies in diverse areas such as solid mechanics, micro-fluidics, thermal management, transdermal sensing, in-vitro technologies, packaging for environmental protection to computed tomography and x-ray source development, and more.

  • Expert at integrating knowledge-driven design; developing and managing multi-disciplinary teams and processes; designing/planning/prioritizing/standardizing/budgeting/managing engineering organizations at the resource, team, departmental and infrastructural levels.

 

KEY SUCCESSES

  • Triple Ring Technologies.  Built a productive, respected mechanical engineering team from 0 to 10+ FTE with variable staffing of 2 to 6 consultants and contractors. Led the design of a novel, robust, x-ray system C-arm.

  • MAP Pharmaceuticals. Finalized Metered Dose Inhaler (MDI) based breath actuated inhaler design for clinical trials. Established fundamental forces using simple fixtures and tests and corrected fundamental design flaws related to MDI valve actuation.

  • Aradigm. Managed SBIR Phase II project —“Pulmoshield”(for measles vaccination in the third world). Conceived of and developed a successful, all-mechanical, version of Aradigm’s AERx. This included a new architecture for the AERx electromechanical extrusion engine. Utilized thorough analysis of architectures and a staged program of simple prototypes and careful testing.

  • Abbott Laboratories. Led radical redesign of IV pump to reduce parts count and cost.

 

KEY SKILLS

  • Disciplined (sub-functional) building-block approach to problem-solving and design.

  • Thorough understanding of phased medical device development and design controls. Ability to identify key design elements and areas requiring focused effort for speedy development. 

  • Expert mechanical engineer with hands-on experience in: robotics and mechanism design – motor, human, and stored energy powered; plastic, metal injection molded and powdered metal part design; managing stresses and deflections by appropriate deployment of materials; machined and sheet metal component design; classical analytical methods – kinematics, stress/strain, etc.; mechanical CAD and Finite Element Analysis (FEA); conductive and convective heat transfer; percutaneous, pulmonary, and transdermal drug delivery.

  • Flexible, adaptable approach to problem-solving has enabled me to make mission-critical contributions in designs from handheld devices (using high-volume manufacturing methods) to large capital equipment (using weldments and other appropriate low-volume manufacturing methods). 

  • Adept with laboratory and assembly tooling and fixtures; good laboratory and data analysis skills, including DOE; and hands-on-capable computer skills with team-relevant applications: PTC Creo and Windchill, Solidworks, Mathcad, Matlab, Mechanica, Comsol.  MS Excel, Word, Powerpoint, Project, and Visio.

 

PROFESSIONAL EXPERIENCE

Triple Ring Technologies | Newark, California | Feb 08 –  May 17

Vice President of Product Engineering | Nov 16 – May 17

  • Responsible for product engineering activities engineering including mechanical, verification and test, NPI and manufacturing engineering, and product systems engineering

    • Incorporated DFM/A into routine design activities

    • Lead project and functional activities with consistent advocacy for knowledge driven methods

    • Practice area lead for business development in percutaneous drug delivery – autoinjectors, on-body injectors, pen injectors, etc.

Vice President of Engineering | Jan 15 – Nov 16

  • Responsible for all engineering sub-disciplines: hardware, software, mechanical

    • Improved cross-disciplinary communications and collaboration

    • Implemented revenue projection and resource demand tools

    • Active in client engagement and business development/proposals, applying data-driven design methods to improve client outcomes

Vice President of Engineering Operations | Jan 14 – Jan 15

  •  Responsible for mechanical engineering group, projects and all engineering operations (resource management tools and methods)

Senior Director of Engineering Operations | Apr 11 – Jan 14

  • Responsible for mechanical engineering group, projects and building internal processes and methods for integrated data management across all of engineering

Director of Mechanical Engineering | Feb 08 – Apr 11

  • Responsible for mechanical engineering activities, project and technical leadership.

    • Defining and implementing engineering organizational best practices (staff development, recruiting, engineering, functional and project management), and direct-design contributions.

    • Building a mechanical engineering functional team and infrastructure.

      • Installed MCAD (ProE and SW) and Product Data Management (PDM) tools.

      • Spearheaded installation of a machine shop with appropriate training.

    • Mechanical engineering development of a large advanced x-ray system.

      • Gantry, detector, collimator, cooling, electronics packaging.

    • Extending native x-ray source technology to meet requirements of new application.

      • Phased technology development – addressed fundamental concerns through two feasibility and specification development programs.

      • Planned and budgeted full engineering prototype development project.

    • Leading and contributing to various client-funded projects – on-budget, on-time, satisfied clients. (Technical and project budget and timeline responsibilities.)

    • Authoring multi-level proposals and budgets.

 

MAP Pharmaceuticals | Mountain View, California | Apr 07 – Feb 08

Mechanical Engineering Manager           

  • Responsible for leading a team of mechanical engineers in readying an MDI based aerosol drug delivery system for late stage clinical trials.

    • Implemented MCAD and PDM systems.

    • Managed internal team of two engineers, and outside consulting team of as many as 6 engineers.

    • Led development of special tools to enable understanding of fundamental characteristics.  Used rigorous tolerance analysis methods to ensure high yield.

 

Abbot Diabetes Care| Alameda, California | Aug 06 – Apr 07

Engineering Design Lead             

  • Responsible for leading a team of mechanical engineers in the design of a novel, integrated glucose meter. 

    • Included multi-shot injection molded disposable (>109 per year), multi-shot, multi-component disposable (> 107 per year). 

    • Led effort to iterate design of a highly complex battery operated, microprocessor controlled, motor driven device to improve function and reliability with DFM/A focus.

  • Organized efforts to maximize opportunities for distributed decision making and individual ownership, while encouraging good team communications.
     

Aradigm Corporation| Hayward, California |  Jan 99 – Jul 06

Principal Mechanical Engineer | Drug Delivery Research | Jan 03 – Jul 06

  • Led a drug delivery technology assessment survey of drug delivery. 

  • Led the development of a new aerosolization technology with funding from an SBIR contract with the Centers for Disease Control and Prevention (CDC&P).  Functioned as project leader and lead mechanical design engineer. 

    • Integrated the technology, and developed benchtop systems and test methods. 

 

Senior Staff Mechanical Engineer | New Technology Research | Oct 00 – Jan 03

  • Conceived of a new all mechanical device for Aradigm’s AERx technology.   Overcame major design challenges and integrated key usability related design features.

    • Led an extensive development program beginning with simple, functionally decomposed, benchtop sub-system prototypes. 

    • Integrated these functional sub-systems into a handheld device. 

 

Staff Mechanical Engineer | Mechanical Engineering | Jan 99 – Oct 00

  • Conceived of and designed a mechanism for the AERx iDMS system for management of insulin dependent diabetes.

  • Technology survey, basic analysis and testing for robustness and efficiency, and concept development. 

  • Used FEA to evaluate structural attributes of key components and moldflow simulation to evaluate filling and residual stresses of several plastic injection molded components. 

  • Managed a tooling program for about 30 components including plastic injection molded, metal injection molded and powder metal components.

 

Cholestech Corporation | Hayward, California | Apr 98 – Jan 99

Senior Mechanical Engineer/Project Manager

  • Responsible for design of new production equipment, management of consultants (laser, machine vision, general machine design), and sustaining engineering for current products.

 

SRI International | Menlo, California | Jan 96 – Apr 98

Research and Development Engineer   

  • Primary assignment was to work as a member of a small group of scientists and engineers to develop surgical robots. 

  • Duties included design of components for robotic manipulator arms and drives, end effectors, modeling virtual environments, and dynamics and controls.

 

Abbot Labs, Hospital Products Div. | Mountain View, California |  Jul 89 – Jan 96

Project Engineer, Senior Member of Technical Staff |  Jul 93 – Jan 96

  • Lead ME for the design of a radically smaller IV pump mechanism

  • Lead ME for the design of a next generation intravenous (IV) pump. 

  • Responsibilities include pumping mechanism architecture, detail design and analysis, and interface with project manager and other leads on system issues. 

  • Also responsible for the pump control methodologies for accurate and reliable sensing of fluid pressure, mixing of fluids, and delivery to the patient. 

Member of Technical Staff | Jul 89 – Jul 93

  • Designed a successful new enteral pump with flushing feature. 

  • Defined architecture and led mechanical team in the design of a new plastic mechanism that minimized fasteners, parts count and adjustments for cost savings of about 65%. 

 

EDUCATION

MS |  Mechanical Engineering, Santa Clara University, Santa Clara, CA. Concentration in Dynamics and Control.

BS | Mechanical Engineering, Northwestern University, Evanston, IL. Tau Beta Pi, Dean's List.

PATENTS

9,257,207 - Funk; Tobias, Wilfley; Brian, Holst; Peter A. “Multi focal spot collimator”.

7,402,154 - Holst; Peter A., Krajewski; David A., Maske; Rudolph J.  “Method for compensating for pressure differences across valves in cassette type IV pump”.

 6,942,636 - Holst; Peter A., Krajewski; David A., Maske; Rudolph J.  “Method for compensating for pressure differences across valves in cassette type IV pump”.        

6,497,680 - Holst; Peter A., Krajewski; David A., Maske; Rudolph J.  “Method for compensating for pressure differences across valves in cassette type IV pump”.

6,375,577 - Smith; Thomas L., Holst; Peter A. “Universal Style Coupler”.

6,285,155 - Maske; Rudolph J., Bunyard; Marc R., Holst; Peter A. “Pseudo half-step motor drive method and apparatus”

5,718,569 - Holst; Peter A. “Dual plunger cassette pump”.

5,583,280 - Mo; Frank S. C., Kelly; Michael E., Holst; Peter A. “Air bubble sensor with simplified mounting of piezo elements”.

5,554,115 - Thomas; V. Stanton, Holst; Peter A. “Sensor for measuring pressures in a cassette pump proximal and distal to a pumping chamber”.

5,431,627 - Pastrone; Giovanni, Poli; Robert G., Yung; Anthony C., Holst; Peter A. “Cassette identification system for use with a multi-program drug infusion pump”.

D342,312 - Pastrone; Giovanni, Holst; Peter A. “Pump cassette”.

 

PUBLICATIONS

  • Noymer, P., Schuster, J., Holst, P., Rosell, J., Ament, B., Wilbanks, T., Srinivasan, S., Morishige, R., Farr, S., (2004) “AERx®-Essence: Efficiency and Breath Control Without Electronics”, Respiratory Drug Delivery IX.

  • Schuster, J., Ament, B., Walsh, M., Holst, P., (2006) “Development of a Novel Single Dose Inhaler”, Respiratory Drug Delivery X.

  • Holst, P., Tin, R., Ament, B., Walsh, M., Schuster, J., (2006) “Pulmoshield – A System for Pulmonary Vaccination”, Respiratory Drug Delivery X.         

   

Peter Holst
Aproio: we analyze, design, build & test medtech and other highly regulated products