HOSSEIN ZEINALI

San Diego, California *****

Cell 858-***-****

ad0p96@r.postjobfree.com

linkedin.com/in/hossein-zeinali

Multi – Discipline Engineering Leader

Quality Engineering Compliance Supply Chain Manufacturing Operations R&D Systems Engineering

SKILL SUMMARY

Full "Cradle to Grave” program activities from inception to launch, mentoring others and building team spirit.

Led compliance remediation program, FDA audit readiness initiatives, identifying risks and driving CAPA resolutions.

Experience in spinal surgery medical devices, implants, and electro/mechanical medical devices.

Utilize Six Sigma Model DMAIC & DFSS - Driven Solution, Lean Principles Mapping and critical to quality (CTQ).

Implement Full Hazard & Risk Assessment (ISO 14971), ISO 13485 – FDA 21 CFR part 820, IEC, CMDR, and QSR.

Audit supplier's quality systems and manufacturing processes, including critical production processes at sub-tiers.

Excellent communication skills, ability to develop a strong partnership with suppliers.

Ability to execute quality methods and systems (statistics, reliability, sampling, and auditing, problem solving)

Strong Design Checking skills along with expertise in ISO/ASME Y14.5 Standards and GD&T.

Utilize Earned Value Management System (SPI & CPI), SAP, Oracle, TFS, DOORS, SPC & Theory of Constraints.

Expertise in R&D design, manufacturing, testing matrix, QA / QC / SQE / FTA / MTBF / EVT / DVT and V&V.

Expertise in Finite Element Analysis modeling (static & dynamic), shock & vibration, EMC / EMI / RF & GMP.

Experience in DFMEA, PFMEA and FMEA (Failure Mode and Effect Analysis), process validation and testing.

Experience in scientific plastic injection/extrusion molding & tooling for infusion pumps/dispensing cabinets.

SME / SQE management / Regulatory, Quality & MFG Operations teams to meet 60601-1 and 62304 requirements.

Experience in automated high-accuracy die attach, wire bonding - pick & place components.

COMMODITIES EXPERIENCE

Materials: Composite, Epoxy based with fibers (carbon or glass), Titanium Alloys, Tungsten, Mild Steels and Stainless Steels with carbon variation and quench (water or oil) for range of hardness, Aluminum (7 series), Nickel Silver Alloy, Plastics (6/6, 6/12 Nylon, polycarbonate, ABS with conductive and nonconductive fibers).

Manufacturing Fabrication Process: Manufacturing Fabrication Process: Die Casting, Centrifugal Casting, Forging, Multi – axis turning and milling, Swiss screw machining, Wire EDM, Powder metal, Investment casting, Injection molding, metal machining, metal stamping, Extrusion, ultrasonic or laser welding, fully-automatic, high-speed, precision, hybrid PCBA components assembly and PCBA testing.

Surface finish process: Powder Coating (electro-discharge and heat process), Plating, Anodizing, Electro polish, Robotic polishing, Sputtering, Painting, X – ray and CMM inspection.

Supplier selection and qualification process

PROFESSIONAL EXPERIENCE

ALPHA TEC Inc., Carlsbad, CA 5/2022 ~ 10/2023

R&D Staff Engineer

Develop cutting edge medical device products (SafeOp) and manufacturing capabilities from early-stage design through successful market introduction and launch.

NPI development projects and verification & validation efforts.

Utilizing external testing facilities to execute safety testing / EMC (60601-1 & -2, 62304 SW)

R&D project focal point of the development, design, implementation, analysis, reporting, and maintenance of R&D project plans, including business case development, scoping, resourcing, and lessons learned.

Injection molded plastic part design, mold flow analysis and processing, tooling design and procurement.

Ability to work within a highly matrixed organization. Utilize LEAN, Six Sigma, DMAIC and other process improvement tools and principles as appropriate for day-to-day problem solving and continuous improvement. Deve

lop and release new products and processes using customer or internal specifications.

Write and execute process and equipment validations (IQ/OQ/PQ), as well as associated risk management activities (PFMEA/Risk Assessment). Drive utilization of process improvement techniques to solve technical problems and make scale-appropriate equipment and process recommendations.

BIOCEPT Inc., San Diego, CA 6/2021~ 5/2022

Sr. NPI Quality Project Engineer

Lead and drive cross functional and multi-geographic team members to fulfill objectives.

Manage compliance of supplier performance to quality requirements and new product introduction to MFG.

Design and develop manufacturing procedures, tooling, and fixtures that result in sufficient capacity to meet customer demand while also promoting product quality and process efficiency.

Create electro - mechanical / systems design requirements.

Generate and modify NPI process documentation and assure that NPI processes and related documentation follow established policies and procedures.

Risk Management Project weekly review meetings and full Risk Assessment Implementation.

INOVIO Pharmaceuticals, Inc., San Diego, CA 6/2020 ~ 6/2021

Sr. NPI Project Engineer

Provide design solutions, specifications, and compliance matrix for MFG / QSR / FDA / RoHS. Act as a liaison between internal customers at all levels (quality, operation, engineering leadership, NPI Teams) and external supplier contacts. Create Concurrent Product and Process Development (CPPD), New Product Introduction (NPI), and Continuous Improvement. Write / review and approve protocols / reports for DVT, V&V for CELLECTRA™ 2000 series, 3PSP and 5PSP products (Synthetic DNA technology targeted against Cancers, Covid - 19 and infectious diseases).

Lead NPI development projects and verification & validation efforts.

Utilizing external testing facilities to execute safety testing / EMC (60601-1, 62304 SW and ISTA for packaging).

Contribute to Design Control activities - requirements, specification development, design verification / validation.

Manage compliance of supplier performance to quality requirements and new product introduction to MFG.

Creating specifications based on requirements, Supporting NCMR, MRB and CAPA.

Project/Program Management - Stage and Gate business systems for product development and PMO.

Identify quality issues/discrepancies and effectively resolve discrepancies within the organization.

DJO GLOBAL, Vista, CA 2/2018 ~ 4/2020

Sr. NPI Quality Project Engineer

Lead and drive cross-functional and multi-geographic team members to fulfill objectives.

Define and manage Verification/Validation strategies for all areas of Verification/Validation, based on business needs.

Validate inputs and feedback from core team and stakeholders to ensure project plan and schedule reflects reality and fulfills expectations. Proactively manage the critical path activity and risks/countermeasures to maintain timely execution despite adverse occurrences.

Create electro - mechanical / systems design requirements / specifications, reliability requirements for electro - mechanical devices and components used for medical devices (Spine Bracing, Cervical Collars, CMF - Bone Growth Stimulation and wired & wireless complex - muscle stimulation).

Collaborate with Manufacturing, Quality Assurance, Quality Engineering, and Regulatory on all aspects of supplier quality and quality system compliance (Concurrent Engineering - S/W, H/W and Systems).

Evaluate and qualify Suppliers to ensure technical and quality requirements can be met. Manage corrective actions, rework plans and non-conformances. Provide suppliers with inspection criteria prior to manufacturing. Manage process validations and process improvements utilizing DFSS - SPC, maintain and approve vendor list (AVL)

Create and implement Supplier Corrective Action Requests (SCAR) when necessary.

CARDINAL HEALTH / CAREFUSION / BD, San Diego, CA 3/2008 ~ 1/2018

Senior Principal Systems Engineer / Principal / Senior R & D Quality Engineer (Health Care Industry)

Work closely with upstream marketing, program management, engineering, hardware, firmware, and electrical engineering teams to define, refine, and execute product, system, subsystem, and modular designs. Establish & work with cross-functional/multidepartment teams to address customer needs, translate needs into product.

Supporting system-level verification testing and validation testing efforts.

Accountable for achievement of both performance and financial goals for overall areas of responsibility.

Establish and work with cross-functional/multidepartment teams to address customer needs, translate needs into product requirements and verify that design output meets design input. Troubleshoot problems/obstacles, define action plans (timelines and milestones) and engineering solutions.

Collaborate with Manufacturing, Quality Assurance, Quality Engineering, and Regulatory on all aspects of supplier quality and quality system compliance (Concurrent Engineering - S/W, H/W and Systems).

Analyze and interpret testing results activities and prepare technical presentations for stakeholders and management.

Lead product and platform architecture and concept development team for instruments / disposables, incorporating voice-of-customer (VOC), manufacturing, operation, supply chain, and engineering inputs.

Lead and coordinate Quality Management Review meetings and full Risk Assessment Implementation (14971/ 60601)

Design, execute and document moderately complex DFMEA, PFMEA, FMEA (Failure Mode Effect Analysis), process validation and testing in compliance with cGMP's, ISO 13485 – FDA 21 CFR part 820, ISO, IEC, MDR, QSR and expertise in Installation / Operational / Process Qualification (IQ/OQ/PQ) and OSHA.

Perform appropriate analyses/evaluations to make recommended changes and identify corrective actions and prevention actions (CAPA), performing MTBF (mean time between failures), ANSI 14.5, and stress analyses.

Responsible for verification of designs by utilizing shock, vibration, noise, heat transfer, ESD, EMI and environmental susceptibility impact. Providing technical information for CSA, UL, cUL, FCC and CE.

Evaluate and qualify Suppliers to ensure technical and quality requirements can be met. Manage corrective actions, rework plans and non-conformances. Provide suppliers with inspection criteria prior to manufacturing. Manage process validations and process improvements utilizing DFSS - SPC, maintain and approve vendor list (AVL).

Coordinate and communicate with R&D, manufacturing, technical support, and materials management to ensure awareness of product / MFG related issues and change notifications.

ENGINEERING CONSULTANT, San Diego, CA 2006 ~ 2008

Multi-Discipline Senior Project Engineer

Provide design solutions, specifications, and compliance matrix for MFG / QSR / FDA / RoHS. Act as a liaison between internal customers at all levels (operations leadership, engineering, NPI Teams) and external supplier contacts. Create Concurrent Product and Process Development (CPPD), New Product Introduction (NPI), and Continuous Improvement.

Design equipment, fixtures and methods required to perform inspections, including gage R&R's, CMM (automation) and provide first article inspections and results.

RAYTHEON, San Diego, CA 2002 ~ 2006

Senior Systems Engineer II - Control Account Manager

Responsible for and managed a $5 million Navigation System development project. Responsible for detail design and design substantiation of new state-of-art electro-mechanical components and systems. Collaborate with external and internal customers to define technical and programmatic requirements.

Manage work performance across multiple sites and with major subcontractors provide technical direction and guidance to design and analysis specialists.

Establish and closely monitor milestones in adherence to program master plans and schedules.

Manage and direct project plans and schedules, milestones, goals, budgets, agreements, contracts, and issue resolution.

Perform computer simulations for design verification. Execute a quality and continuous improvement strategy that aligned with both the corporation, manufacturing and operation facility’s vision and mission.

Initiate projects to support cost reduction, capacity, and continuous quality improvement initiatives through the effective use of Lean Principles (Value Stream Mapping), and Design for Six Sigma (DFSS).

Project Engineer / Senior Multi Discipline Systems Engineer

Lead EQT testing, support documentation and failure analysis. Create and implement compliance matrix for environmental testing (MIL-STD 461, 810 and 901) according to SOW / PDR / CDR. / EVT / DVT / V&V.

Manage compliance of supplier performance to quality requirements and new product introduction to MFG.

Interact, review, and analyze root cause corrective and preventative actions for resolution and effectiveness.

Interact with over 25 suppliers to review and analyze root causes and take corrective and preventative actions.

Experienced with high-strength metal machining, metal stamping, laser welding tooling and injection molding.

EDUCATION

MSEE, West Coast University, Los Angeles / San Diego, CA

BSME, California State University, Sacramento, CA

PATENT

Patent Number: 5542598 Title: Tape Guides for Magnetic Tape Equipment.

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