Jonathan Meltzer Email & Phone Number

Assisting medical device and IVD startups with Quality Management Systems and Product Development

Waltham, Ma, Us

• Managed 60+ person project in phase gate development of a novel Class III Point-of-Care medical device that electrically generates nitric oxide (NO) gas from air and delivers it to treat ventilated neonates and adults with persistent pulmonary hypertension. • Led cross functional team through Product Realization Process. Responsible for project deliverables and DHF. Led project from Voice of Customer and feature assessment, through user needs and requirements definition, Harms and Hazards analysis, DFMEA, architecture, project planning, human factors formatives, design, and hardware / software integration testing, contract manufacturer selection and set up.• Worked closely with technical leads to manage daily hardware and software engineering activities.• Weekly relationship management of major pharmaceutical commercialization partner. • Regular reporting to Senior Management and Projet Steering Committee. Monthly technical reviews and quarterly project reviews.

Providence, Ri, Us

Work with start up clients managing early phase requirements definition and proof of concept designs for IVD devices. • Client Management, budget estimating and tracking using Power Bi, project scheduling and reporting, managing engineering team.• Led 2 month client proposal conceptualizing a high throughput Automated Molecular Diagnostic system for PCR (similar to Hologic Panther or ROCHE Cobas 6800). Team mapped required workfows, estimated rate limiting steps, conceptualized new system workflows and industrial design, investigated with Volpi a customized 6 color optical reader, and presented 3 alternate concepts for client. Resulted in proposal being selected after a competive bidding process against other engineering services firms.• Led engineering team in electronics design, instrument layout, and mechanical design of a point -of-care blood analyzer. Weekly client management.

Shelton, Ct, Us

• Managed 30+ person development project from requirements to verification to add new automation features for Class I IVD JANUS automated liquid handler platform. Developed SCARA robot and a remote video monitoring system streaming video to Android and iOS mobile phone applications. • Feasibility for Blood iQ feature using imaging and AI algorithms to detect and extract blood buffy coat layer. • Mechanical, electrical, software, firmware development. Offshore and 3rd party development. New supply chains. • Led team in documenting DHF and releasing a Class I IVD integrated liquid handler and DNA extraction system. • Instilled sense of urgency and focused team to pull in Class I IVD project by 6 weeks to deliver $600K revenue.

Oslo, No

IDEX America designs and sells biometric fingerprint sensors and authentication technology for mobile, embedded and Smart Card applications. www.idex.no• Managed product development and customer qualification programs for a Startup developing leading edge off-chip capacitive biometric fingerprint sensors intended for Mobile phone, IoT and Smartcard markets. • Requirements definition, concept, layout, firmware and software development, NPI, verification and 8D analysis. • Managed geographically dispersed team with members in US, Norway, China, UK, Armenia, France. • Defined, implemented, trained org in a paperless Engineering Change Order (ECO) process based on Arena PLM.

Lübeck, Schleswig-Holstein, De

• Led sustaining design changes to address design and supplier quality issues on Class II medical device Infinity Acute Care System M540 and M300 transport patient monitors. Managed team with engineering, supplier quality, manufacturing and supply chain to reduce field failures and production failures. Led team in applying Six Sigma methods to identify root causes and implement design improvements reducing rates from over 15% to under 6% with annual savings $4M. • Managed and acted as technical lead for hardware design improvements to Non-invasive Blood Pressure system. Subject Matter Expert for micro-valves, miniature pumps and micro-motors. • Led division’s regulatory project to comply with FDA Unique Device Identification (UDI) regulations.• Knowledgeable and experienced with ISO 13485. • Represented hardware on cross-functional program teams for software feature releases and 3rd party integrations.• Requirements definition, product specifications, Hardware verification, Trace matrix, Production Validation (IQ, OQ,PQ) • Complaint investigation, Failure Analysis, CAPA, FMEA.

• Co-authored and secured grant for novel hybrid solar system at Tip O’Neil Federal Building Boston. • Managed installation of a hybrid solar photovoltaic / thermal system at Tip O’Neil Federal Building in Boston. • Business development including responses to RFPs, project quoting and customer management.

Boston, Ma, Us

• Led team in a regulatory project to create a Medical Device Technical File for an acquired Class I product line. • Led team in gap assessment and creation of Technical File for SEBRA Radio Frequency (RF) Tube Sealing System. • Led redesign effort to meet CISPR 11 Class B radiated emissions.

North Reading, Ma, Us

• Internal Startup (Storage Test) new platform development of $1.8M+ high complexity disk drive tester (Neptune). Custom mechanical, electronics and automation to test 4800 drives. Managed prototype builds of system with over 1000 system components. Identified new supply chains, managed materials risk, supplier DFM and ECO to rapidly turn design changes. Delivered prototypes on-time to secure a $31M design win. Project successfully went from architecture to shipping production units from Asia in 13 months. • Led division’s enterprise-wide project for RoHS compliance. Defined risks and product specific strategies, implemented part compliance database and managed contract manufacturers in piloting lead-free PCBA builds. • Managed New Product Introduction (NPI) teams including CMs, Purchasing, Test Development, Commodity Eng., Production Planning, Product Mgt and HW Eng in executing DFM, pilot builds, ECO, rework, test development, MRP and ramp. Represented Operations on core project teams. Responsibility to deliver to revenue commitments.

North Reading, Ma, Us

• Functional Manager for an electrical design group with 14 direct reports. • Led cost down redesign project for flagship product TestStation In-Circuit Test platform. Complete mechanical, electronics and embedded software redesign. Achieved 30% COGs reduction. Still the flagship platform in 2024.• Defined projects scope, budget and ROI. Created work break down structures, schedules, risk plans. • Managed organization’s project portfolio with capacity planning and metrics. • Used Six Sigma methods to lead improvement teams in root cause analysis for corrective actions.

North Reading, Ma, Us

• Implemented a Program Management Office for 144 person engineering group. Took a lead role in helping transform organization installing a phase-gate process, capacity planning, scheduling and critical path analysis, risk management and metrics to allow senior managers to make data driven decisions. Results reduced the project portfolio’s aggregate slip rate from greater than 30% to less than 2%.• Integrated engineering groups and product lines following company acquisitions. • Led cross-functional teams of engineering, verification, technical doc, product management, operations and service. Instilled teams with ownership and sense of urgency to overcome obstacles and meet commitments. • Managed design projects including in-circuit test platform re-design, PXI functional test platform, optical power meter, signal conditioning module, software drivers, backplane, controller boards.

Ashland, Ma, Us

•Globally recognized technical expert at the forefront of development of clean agent fire protection in the 1990s. Set technical direction for $100M product line. Architected products and led enabling technology and hardware development projects for chemical suppression agents, valves, nozzles, pressure vessels and an explosive actuator. One patent.•Functional manager for an 11 person R&D engineering group.• Assessed new technology performed competitor analysis and provided business recommendations. Supported product management with requirements definition, technical presentations, trade shows and product launch.• Led technology transfer to divisions in UK, Germany, France, Italy and Japan. • Managed regulatory approvals with US (UL, FM) and European (VdS, LPCB) compliance agencies. • Served on NFPA 2001 Standard on Clean Agent Fire Protection committee and UL committee for Halocarbons developing national and international fire protection standards.

Ashland, Ma, Us

•Expanded fire suppression product lines. •US and international compliance agency approvals: UL, FM, VdS (Germany) and LPCB (England). •Technology transfer and product introduction to divisions in UK, Germany, Italy, France, and Japan.

Ashland, Ma, Us

•4 years experience managing commercial flammability and explosibility testing services working closely with customers to identify customized project requirements and recommend test solutions (60% sales growth)•Conducted large scale fire and explosion tests. Expertise in pressure and temperature instrumentation and data acquisition.

Cincinnati, Oh, Us

Small Engine Compressor Manufacturing Group

Cleveland, Oh, Us

Nuclear and Thermal Systems Group

Bachelor’S Degree, Aeronautical Engineering

Master’S Degree, Aeronautical Engineering

6 Graduate Courses, Fire Protection Engineering And Project Management