Mechanical Engineering

Elliott Alber

**** ********* ****, **********, ** 94566

*******.*****@*****.*** 925-***-****

https://www.linkedin.com/in/elliott-alber-299828

Engineering Technical Lead

20+ years’ exceeding KPIs for medical devices, telecommunications, capital equipment & electronics industries.

I strive for repeated success in planning, and execution of sophisticated engineering design, testing and manufacturing projects. My background in leveraging opto-electro-mechanical engineering, system integration, and product development innovation has allowed me to deliver high-quality devices and products within technical standards and regulatory requirements. I am an expert presenter and competitive negotiator— able to forge strong relationships with strategic partners and build consensus across multiple organizational levels. I have a substantial experience of the development of new systems and sustaining manufacturing processes according to stakeholder requirements

I demonstrated that I am a multi-functional specialist with considerable past experience in managing a variety of international groups working on very different products and projects. I have worked for several recognizable brands including Fresenius Medical Care Inc., PemStar/Benchmark Electronics Inc., SDL/JDSU Inc., Intevac Photonics (DOD) and Sandia National Labs / Lockheed Martin (DOE). All my projects show that I am a driven, hands-on engineering director with a substantial experience in scaling engineering teams from early-stage product development to manufacturing, servicing and sustaining engineering. I can quickly learn the new software, new engineering methods, and any new skills required of me. I remain flexible when working with clients, upper management, and the engineers reporting to me always finding a way to support different people in different project situations.

Product Development &

Qualification

Development and qualification of highly precise and complicated Class III and II medical systems with internal and external partners in compliance with FDA and other regulatory bodies.

Achieve platform design for DFM, Reliability, Serviceability and Modularity

Organizational Leadership &

Growth

Acquire talent, lead and grow competency in engineering

Grow a department across multiple sites stretching across multiple product lines

Establish guidelines, best practices, and standards for organizational growth and excellence

Plan and execute V& V activities

Cross-Functional Project

Management

Lead programs with internal and external partners for product development, process development, and R&D investigations

Lead corporate selection of long-term CMO and Design partners

Take SME assignments as the corporate Device Engineer

Highlights of Technical Expertise

Engineering Design & Product Development

Robotics & Automation Design & Implementation

Manufacturing Operations Management

People Leadership

Team Development

Performance Evaluation

Stakeholder Engagement & Client Relations

Quality Improvement (QFD/RAM)

Quality Standards & Compliance (ISO/FDA)

Research & Development

IP / Patents

Verification / Validation /

Risk analysis / DHF

Cost Optimization

Product Miniaturization

Stress Analysis

Optical Design

Thermal Design / Analysis

Sensor Device Development

Reliability test plans and testing

Production Planning & NPI

Technical Training

Tooling & Assembly Line Product

Process Optimization

Highlights of Projects Experience

More than 20 years of diverse technical operations, engineering management and leadership experience with business analysis and strategic marketing and product roadmap development: forecasting, planning, client program management and retention.

This included hands-on development and production of high-volume opto-electro-mechanical systems (including ultrasonic, optical, electrochemical sensors): design, prototyping, qualification, documentation, automation, fabrication, production yield improvement; project / product management; defect investigation (FMEA) /corrective action resolution (CAPA).

I have a broad experience of development of matrix management organizational structure and setting up multifunctional development teams.

I was leading Product Management, Manufacturing and Sourcing, Quality, Sales and Marketing, Regulatory Affairs in product roll out and customer sales activities.

13 years of biomedical experience:

Artificial Kidneys; Artificial Lungs; Artificial Pancreas (Fresenius; PemStar / Medtronic; M2 Med /Asante Solutions);

actuators / motion control design (Iolon; Intevac Photonics/EOTech);

precision mechanism in nitinol surgical tools and orientation devices for precision surgery (NDC/Confluent Medical; PemStar/Hantel);

flow / oximetry sensors and respiratory air ventilators (PemStar / Medtronic);

novel membranes for filtration and molded plastic disposable cartridges (Fresenius; Sandia National Labs; OptiScan; LumaSense);

lab-on-a-chip type MEMS (Sandia National Labs, ONIX Microsystems);

mechanisms of powder drug delivery devices (Nektar/Inhale Therapeutics);

intravenous delivery systems (M2 Medical/Asante Solutions; OptiScan);

tolerance-critical electro- opto-mechanical fixtures and microfluidic devices (Sandia National Lab; AOSense);

capillary pumps (Sandia National Lab); stents (PemStar/Guidant; NDC)

16 years of military photonics/telecommunications/ sensors/ MEMS/ electronics/ semiconductor equipment development and manufacturing experience including:

IR imaging/ cameras for IVAC project (for Microsoft/DOD AR goggles);

testing and automation engineering of optical switch devices;

instrumentation and packaging development;

Injection molding design and manufacturing (Intevac Photonics);

microfluidic sensors ((Sandia National Labs; ONIX Microsystems);

widely-tunable external cavity laser diodes based on a variety of actuator techniques (from electromagnetic to PZT to Shape Memory Alloy to MEMS based) used in diagnostic devices, biotech equipment, aerospace sensors, telecom (Sandia National Labs; JDSU/SDL; Iolon; ONIX Microsystems; Novalux; InveniSense; LumaSense; Intevac Photonics);

ultrasound and magnetic detection devices and rechargeable batteries (PemStar/Inamed).

Detailed Career Experience

Alber Technologies Inc., Pleasanton, CA

PRINCIPAL / PROJECT MANAGER / PROGRAM DIRECTOR (April 2022 - Present)

Managed thermo-mechanical/surface processing team of 9 engineers and 5 technicians for NDC/ Confluent Medical Technologies; the electromechanical development team of 4 engineers + 1 technician for LumaSense Technologies; the team of 4 engineers for Optiscan Biomedical Corporation, and quality team of 3 engineers for Outset Medical.

Set up a failure analysis laboratory including establishing Quality Management Systems, completing SOPs FA documentation and installing reliability testing equipment and procedures for mechanical and electrical validation for Outset Medical

Project-led the cost saving programme by designing universal IR cameras to accept any market available shutters (guillotine-type, rotary-type, diaphragm) for LumaSense Technologies

Executed design projects including camera enclosures for IPX 67 and cooling/heating with TEC heat pumps (for petrochemical industry applications; semiconductor and general high risk high temperature manufacturing and for a variety of remote sensor applications) for LumaSense Technologies

Developed and transferred into production of gas and vapour monitors based on the infrared absorption and photoacoustic detection principle (PAS). The gas monitors are used for research studies as well as for continuous field measurements of multiple compounds from ppb and ppm level to percent level concentrations for LumaSense Technologies

Enhanced the functionality (mechanisms design) and production process of the IR cameras by simplifying alignment and assembly processes - passive alignment via fiducials for LumaSense Technologies

Designed sensor systems for Applied Materials for LumaSense Technologies

Developed new tools for additive manufacturing (e.g. 3D printing/ metal sintering/process automation/robotics) for Confluent Medical Technologies; Optiscan Biomedical Corporation.

Maintained quality standards (based on regulatory requirements - GMP, ISO, MDD) on products and processes to ensure accuracy in laser cutting of drawn NiTi tubes, in de-burring and chemical surface processing, and in measuring the final implantable devices for Confluent Medical Technologies.

Spearheaded adoption of improvements in the manufacturing by establishing a pilot line for the nitinol implantable products (for Confluent Medical Technologies).

Optiscan Biomedical Corporation, Inc., Hayward, CA, USA

PROGRAM DIRECTOR (January 2017 to September 2020)

Set-up and managed an engineering team comprising of 5 engineers and 2 technicians and one drafter.

Used my robotics/ automation/ actuators expertise to develop assembly/ test stations on the production line.

Designed / produced pilot line fixtures for automated adhesive joining of disposable cassettes for sepsis diagnostics.

Developed new tools for additive manufacturing (e.g., 3D printing/ metal sintering/process automation).

Created high-precision, high-throughput industrial designs for material handling, metrology, process automation, and general instrumentation.

Developed cost-cutting simplifications for the OptiScanner 5000.

The OptiScanner 5000 is a bedside glucose monitoring system that measures values directly from plasma using spectroscopy technology without the need for constant calibration with a single-use disposable cartridge that is swapped out for every patient. Once activated, clinicians can see both real-time glucose measurements, and trends over time. This helps to quickly identify cases of hypoglycemia, hyperglycemia, and helps to assess patient glycemic variability. The same mid-IR technology is used to detect additional analytes within the same blood sample. Lactate and ScvO2 levels (lactic acid concentration and central venous oxygen saturation) are recognized as early warning signs of sepsis, and an indication of patient response to sepsis treatment.

Improved measurement of glucose (in the middle infrared) by using a rapid cooling on the skin surface which detects glucose in a phase-shift using 29 different wavelengths of IR radiation in the 9 - 10 micron.

Simplified automated delivery system of the blood sample to the analyzer.

Developed FEA/CFD models/simulations to optimize the micro-centrifuge in the disposable cassette of the OptiScanner 5000 with computational fluid-structure interaction techniques.

EOTech / Intevac Photonics Inc., Santa Clara, CA

ELECTROMECHANICAL ENGINEERING DIRECTOR (September 2020 to March 2022)

Set-up and managed engineering team of 3 engineers and 5 technicians for ITAR programs in the field of the defense with some commercial applications.

Provided operational leadership, technical operations expertise, people development, and promoted a culture of innovation, responsibility, and personal growth.

Responsible for hiring, mentoring, and growing multidisciplinary cross-functional project teams

Implemented development processes to drive “on time” team execution and meet business goals.

Designed night vision cameras with special heat pipes cooling and TEC heat pumps (with the latest semiconductor photocathode technology and silicon-based video electronics) for defense industry.

Performed reliability (shock and vibration) testing and developed corresponding improvements in the manufacturing processes for IVAC project (for Microsoft/DOD AR goggles system).

Improved the functionality and production processes of the existing night vision cameras by smart compact integration of electronics, sensors, displays, flex circuits, connectors, wires, etc.

Used my robotics / automation/ actuators expertise to develop test stations on the production line.

Performed CFD computations to achieve optothermal stability in optomechanical systems - athermal design

Fresenius Medical Care, Concord, CA; Lausanne, Switzerland; Lake Forest, CA;

MECHANICAL AND RELIABILITY ENGINEERING DIRECTOR (September 2012 to December 2016)

Set-up, hired and managed three engineering teams comprising of:

14 Engineers / 3 Technicians to transfer “in-clinic” haemodialysis capital equipment into production;

3 Engineers / 1 Technician to bring “at-home” peritoneal dialysis devices through FDA approval process;

17 Engineers / 2 Technicians to bring “at-home” haemodialysis devices through full development lifecycle (from conceptual design to PRD (UID and EID) development to NPI to production start-up, including building a prototype, validation/ verification testing; transfer into high volume manufacturing and corresponding automation assembly and test stations design and set-up and post-release product surveillance;

Developed and executed an FMC tech strategy for the organization by leveraging “matrix management” organizational structure with introduction of reliability electromechanical analysis and cost-reduction analysis of the products as required steps prior to transfer to manufacturing.

Improved key processes such as reducing time-to-market; improving design for manufacturability; improving digital prototyping and testing, and driving down cost to manufacture while maintaining innovation and IP.

Lead the development, testing, and manufacturing of 2008T kidney dialysis machines with innovative sensor designs for conductivity, pressure, flow measurements, and ultrasonic bubbles counting for substantially improved global health outcomes.

Enhanced the design, functionality, reliability, and maintenance of at-home and in-clinic kidney dialysis machines by delivering robust “plug-and-play” sub-systems for manufacturing of 27,000 units per year.

Hired and set-up management of local (and remotely located) teams ensuring that the development was performed with quality using six-sigma and other DFR methodologies.

Established and managed the group’s capital and projects budgets.

Monitored the scheduled performance and drove day-to-day execution, ensuring quality, schedule adherence, and execution to budget.

Streamlined mechanical engineering design, testing, and validation procedures, including ETR protocols, statistical sampling, technical specifications and technical management of reliability testing.

Executed COGS reduction plans to meet and exceed budgeted costs and gross margins.

Attained compliance with ISO 14971 requirements in executing DHF maintenance processes: mFMEA, dFMEA, hazard analyses, new risk management matrices, and EIDs-based remediation.

Ensured completion of the development, transition to product, transition to service, and internal and external customer satisfaction for all FMC products in adherence to the schedule, scope, and budget requirements.

Established the Reliability Testing Lab using actuators (pneumatics and hydraulics based) in Concord as a Centre of Excellence (COE) for the entire organization.

Performed (through local managers) sustaining engineering tasks (including timely replacement of obsoleted components) and operations management with external partners and vendors.

Developed effective, strong and measurable performance management and hiring practices.

Coached/mentored/maintained the growth of the technical multifunctional teams (TMT).

Alber Technologies Inc., Pleasanton, CA

PRINCIPAL / PROJECT MANAGER / PROGRAM DIRECTOR (March 2006 to August 2012)

Expedited the engineering design and development of specialized products for client organizations by conducting data analysis, reliability testing, and related procedures on prototypes. Provided technical support to teams of Engineers, Designers, and Technicians during project implementation.

Developed atomic optics sensors to manufacture inertial, gravity, and general cold atom sensor packaging to survive temperature cycling, shock, and vibration protection for AOSense Inc. (The test masses in those sensors are clouds of laser-cooled atoms freely falling in a vacuum cell. Frequency-stable lasers measure the motion of these atoms relative to the sensor platform. These two characteristics of AO sensors provide exquisite accuracy and stability, far surpassing the performance of conventional MEMS sensors.) Replaced adhesives with laser welding as primary joining method. Developed high vacuum hermetic windows welded to the nonmagnetic vacuum chamber. Developed flexure mounts / mirror kinematic holding designs. Performed FEA (ANSYS/COMSOL); optical design with ZEMAX; testing / FMEA of prototypes.

Managed the development of powder drug delivery devices for Nektar Therapeutics Inc. by completing all technical processes including aerosol development and flow calculations. Technical support for clinical research/ clinical affairs / PMA applications / patent development

Oversaw the technical design and development of a stent devices and the associated delivery system for Hantel Technologies, Inc. based on extensive fatigue analysis, and life expectancy calculations.

Completed engineering design (including geometric / statistical stack-ups tolerance analysis) of special earphones containing sensors for measurement of heart rate, oximetry, and pulse for Oxirate.

Led the mechanical (mechanism design with linkages, bearings, and gear trains), electrical (rechargeable batteries), and system design of M2 Medical Inc.’s (Asante Solutions) insulin pump and the associated automated needle delivery system to achieve miniaturization and pass V&V testing.

Performed ergonomics design of ion chromatography machine. Developed an automated sample preparation hardware for Dionex, Inc. (now part of Thermo Fisher Scientific, Inc.)

PemStar Inc., San Jose, CA (currently a subsidiary of Benchmark Electronics, Inc.)

DIRECTOR /VP OF MEDICAL PRODUCT DEVELOPMENT (May 2004 to February 2006)

Delivered engineering design and development of a variety of diagnostics and treatment medical devices for cardiology, gynaecology, oncology, radiology, urology, and vascular surgery. Managed the work of 19 Engineers operating in 3 teams: handheld diagnostics, lab equipment and implantables.

Developed, optimized and prototyped implantable devices - stomach restrictor, its port; catheters, surgical grafts, coronary and urethral stents, polypectomy snares, lithotripsy devices, guide wire compatible stent systems as well as some polymer stents; endoscopic devices.

Expedited the development of affordable and high-volume hand-held ultrasound devices for detection of implantables such as stomach restrictor ports (over 50,000 units per year).

Conducted electromechanical design and testing on chemical chromatography devices for laboratory use (over 20,000 units per year in production)

Introduced the accurate measurements of flow pressure, flow rate, concentration as a result of designing and setting up new LabVIEW based laboratory equipment and instrumentation

Tested a variety of devices for home-based usage, including humidifiers, nebulizers, lung ventilation devices, and oxygen delivery devices following established and new reliability protocols.

Improved the capacity of devices and products to survive vibration, shock, and temperature cycling as a result of utilizing SolidWorks and ANSYS/COMSOL in designing internal and external packaging and conducting FEM/CFD analysis for all biomedical applications.

Owned configuration management for the product and engineering releases.

Engaged with cross-functional management to provide consistent communication and execution in a timely manner; prioritized and met company and department commitments.

Monitored the scheduled performance and drove day-to-day execution, ensuring quality, consistent schedule adherence, and execution to budget.

Ensured compliance with regulatory requirements and paper trail execution for DHF in all technology activities; identified and owned process improvements and innovations development.

Responsible for release of new products into production with full documentation (drawings, specifications, bill of materials, product safety manuals, process qualification documents, etc.) as well as production support/sustaining engineering and yield improvement / cost reduction for a group of new medical devices.

Education & Credentials

PHD IN MECHANICAL ENGINEERING AND APPLIED MECHANICS, University of Pennsylvania, Philadelphia

STRUCTURAL ENGINEERING degree (equivalent to Bachelor of Science in Civil Engineering), MIT/FSU

PMP and Scrum Master Certifications (ongoing) - Project Management

California Professional Engineer registration in Mechanical Engineering #30972

California Professional Engineer registration in Electrical Engineering #16888

Specific Technical Skills

Project Management

CAD/Solid modeling/PDM/PLM: SolidWorks PDM (16 years), ProE /CREO (5 years), AutoCAD (3 years)

FEA experience: ABAQUS/Simulia (14 years), DYNA3D (6 years), ANSYS (7 years), COMSOL (6 years)

CFD experience: Fluent (5 years), COMSOL (6 year), ANSYS-CFX; COSMOS/SW Simulation (4 years)

25 years of heat transfer analysis and stress analysis experience

22 years of experience with MS Project; Jira & Confluence (Atlassian – 3 years), WorkFront (1 year)

11 years of experience of injection molding plastics design and processing

5 years of sheet metal design and processing

Working proficiency with optical design software: Zemax (2 years); Code V (1 years)

Working proficiency with electrical design software: PCB SW (2 years); Altium (1 year)

Robotics and industrial automation experience developing pilot lines and using several techniques for additive manufacturing (e.g. 3D polymers printing; metal alloy sintering) (7 years)

Statistical Tolerance Analysis Software Cetol 6s Sigmetrix (4 years)

Microsoft Word and Excel (20+ years); Microsoft Project (16 years)

Additional Experience

Electromechanical Engineering Manager (11/2002 to 5/2004) Iolon Inc. (now Coherent, Inc.), San Jose, CA

Engineering Manager (1/2000 to 11/2002) Onix Microsystems Inc., Richmond, CA

Project Manager (12/1998 to 1/2002) SDL, Inc., San Jose, CA (now part of Lumentum /JDS-Uniphase)

Sr. Member of Technical Staff (2/1995 to 12/1998) Sandia National Labs - Lockheed Martin, Livermore, CA

R&D Engineer (10/1993 to 1/1995) CIMS, NYC, NY (Funded by Army Research Office)

ADDENDUM

Details of other projects

Electromechanical Engineering Manager, Iolon, Inc., San Jose, CA (now part of Coherent, Inc.) 11/2002 – 5/2004

Responsible for the development of tunable external cavity laser diodes used in diagnostic devices, biotech, telecom. Oversaw the work of five packaging and process engineers.

Administrative responsibilities: new hiring, performance evaluation, team building, etc.

Design of the internal and external packaging to survive shock, vibration, temperature cycling, fatigue. Performed tests and experiments for Bellcore/Telcordia qualification of the joints. Performed FEA (ANSYS).

Tooling and fixture development including robotics automatic equipment for attachment of micro-components including laser cutting, laser welding, coating, laser soldering.

Design and development of precision mechanisms for attachment stations to achieve the precision in placement of +/- 0.5 micron

Mechanical design of tooling and mechanisms for the optical alignment and instrumentation design.

Developed the hierarchy of solders for attachment based on temperature acquisition systems using LabView.

Established Infrared temperature measurement program, numerical modelling and simulation program, and materials properties testing program. Managed laser welding equipment purchasing and development.

Designed optics using CODE V.

(Since Iolon as a start-up company ran out of money, I continued with PemStar).

Engineering Manager, Onix Microsystems, Inc., Richmond, CA 1/2000 – 11/2002

Performed engineering design (optical, thermal, stress analysis) and development of 3D optical MEMS to be used in diagnostic devices, biotech equipment, a variety of sensors and telecom:

Oversaw the work of nine packaging and process engineers.

Administrative responsibilities: new hiring, performance evaluation, team building, etc.

Responsible for testing of MEMS subsystems (light switching technology) to pass Bellcore/Telcordia qualification protocol.

Designed shock absorption mechanism to survive 500G shock test (bubble mounts) and vibration/shock absorption mechanisms to pass 20G vibration sweep test.

Modelled vibration / shock testing using FEA (ANSYS/ABAQUS

Designed new hinges for the mirrors to shift eigenfrequences up and performed optical design using CODE V.

Modelled and developed "CLAM SHELL" hermetic design.

Design of the internal/external packaging to survive shock/vibration, temperature cycling, fatigue.

Tooling and fixture development including robotics automatic equipment for attachment of micro-components including laser cutting, laser welding, coating, laser soldering.

Design and development of precision mechanisms to achieve the precision in placement of +/- 0.5 micron

Managed laser welding attachment of the optoelectronic components.

Mechanical design of tooling and mechanisms for the optical alignment and instrumentation design.

Developed soldering process based on multichannel temperature acquisition systems using LabView.

Established numerical modelling and simulation program. Established product design and QC programs.

(Since Onix Microsystems as a start-up closed and sold the technology, I continued with Iolon).

Project Manager, SDL, Inc., San Jose, CA (now part of JDS-Uniphase, Inc.) 12/1998 – 1/2000

Performed design and verification of semiconductor laser diode components for biomedical applications:

Designed 2-W, 630-nm fiber-coupled laser for use with the light-activated drug Photofrin.

Developed high-power, single-frequency laser diode system suitable for high-precision spectroscopy.

Re-designed the snout of the solid state laser diode to pass qualification tests.

Designed single-mode fiber pigtailing of edge-emitting diode and planar devices.

Designed hermetic sealing, including eutectic soldering/epoxy specification.

Performed finite element calculations using ANSYS/ABAQUS/DYNA: Failure modes analysis, non-linear fracture analysis, thermomechanical fatigue analysis, and transient and steady-state thermal analysis.

Tooling and fixturing development including robotics automatic equipment for attachment of micro-components. Designed all components using Pro-Engineer and SolidWorks. Performed manufacturability / reliability analysis of semiconductor laser diodes.

Used DOE and other statistical tools for data analysis and reliability assessment of solid state lasers for biomedical (photodynamic therapy, ophthalmology, dermatology, surgical cutting, coagulation and dentistry) as well as spectroscopy applications.

Managed all phases of package development including material selection, conceptual design, package prototyping, thermal and structural modelling. Documented all aspects of product design: bills of materials for piece parts, procedures, and test sets.

Supervised engineering work of production line technicians and five process engineers.

Sandia National Labs - Lockheed Martin, Livermore, CA 2/1995 – 12/1998

Technical Project Manager, Materials Reliability Department

Developed, analysed and evaluated a variety of microfluidic devices.

Fracture reliability analysis of thin-film microelectronics components, Nitinol surgical tools, MEMS.

Metallurgy investigation of shape memory alloys, corrosion analysis, fatigue testing, creep testing, manufacturing process development (e.g. electro-polish, coating, crimping, etc.)

CFD and thermomechanical analysis and failure-modes analysis of biomedical MEMS.

Random vibrations / shock analysis of electronics components for the US Department of Energy.

Fluid dynamics analysis and friction / wear / lubrication / erosion analysis for the US Army.

Performed engineering design of guide wire compatible stent system as well as some polymer stents: modelled using FEM/ Finite difference / Finite volume methods blood flow around stent. Designed various vascular graft and stent variants.

I worked on development of a several biopolymer drug release coatings for vascular graft / stent applications.

Sr. Member of Technical Staff / Manager, Structural and Thermomechanical Department

Managed technical performance of staff of two research and development engineers

Developed project quotes, timelines and manpower requirements for given projects, design schedules, etc.

Responsible for reliability investigation of electromechanical systems, components, packages:

Designed and developed electromechanical systems, mechanisms, assemblies, packages, MEMS, etc.

Performed failure-modes analysis and reliability improvement analysis.

Investigated adhesion strength of metallic thin films to ceramic substrates and their reliability.

Generated computer code for numerical simulation of electromechanical assemblies, MEMS, fluidics, boundary layers, lubricating layers, thin films adhesion and their reliability, shape-memory materials, performed verification experiments. (I was recruited to be a project manager at SDL)

R&D Engineer, Materials Department, CIMS, NYC, NY (Funded by Army Research Office) 10/1993 –1/1995

Designed and developed new composite materials with prescribed mechanical and thermal properties.

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