Jenna Zhang

To gain employment where my knowledge and experience may be used to advance the research, product development and new business venture

Consultant - Self-employed

(2025-08)

• Medical device R&D, quality/regulatory, Engineering lead, Project management

Research Lab Director - Children’s Hospital of Philadelphia - Philadelphia, PA

(2025-04 - 2025-08)

• Transitional research; Epic system application; New device development for pediatric spinal deformity, liaison with medical doctors, animal trial, manufacturing, testing, quality and regulatory requirements, etc.

Staff Engineer, Research (Regulatory and quality driven) - Stryker Spine - Allendale, NJ

(2020-01 - 2024-01)

• New product development/Sustaining, Integration, Project management, Quality/Regulatory requirements
• Testing and Simulation, Measurement, Design control Verification and Validation, Navigation system
• Manufacturing process improvement, Cost assessment, Design change, Cement delivery system
• Mentoring and Supervising

Senior Engineer - Stryker Spine - Allendale, NJ

(2020-01 - 2024-01)

• R&D support for successful regulatory remediation/approvals globally such as APAC; GD&T

Mechanical Product Development Engineer-Core Team Lead - Depuy Synthes - Raynham, MA

(2018-08 - 2019-03)

Contract

• EU MDD/MDR Remediation of spinal implant and instrumentation devices in a cross-function team
• Design control (Traceability matrix, V&V, Risk management, Clinical evaluation report)
• Biocompatibility and patient-device contact types analyzing

Massachusetts General Hospital - Boston, MA

(2018 - 2019)

Volunteer

• Biomechanical Research on Foot & Ankle
• Device development for treatment of Foot & Ankle injury

Development Support and Design Risk Engineer (US Site Manager, Design Quality) - Nobel Biocare - Mahwah, NJ

(2017-04 - 2017-12)

Contract

• Design Control and Risk Management in Dental Implant Product Development
• Supplier assessment; Create DFMEA, Risk management plan and report
• Lead design quality team, reviewing all documents required in design control process (Biocompatibility testing report, Mechanical property and efficacy, Change control, PFMEA, etc); Familiar with Medical device ISO (13485, 14971 etc.), FDA regulations and compliances (21 CFR 820); Support audits

Sr. Development Engineer II - Zimmer - Parsippany, NJ

(2014-12 - 2015-07)

Contract

• Lead new product development (orthopaedic implants/materials) and Remediation
• Fatigue testing for total hip arthroplasty responding to customer complaints
• FEA (Finite Element Analysis) Modeling on Total Hip Arthroplasty and spinal implant

Journal reviewer

(2013 - 2017)

• Review articles for top Journals in Biomechanics, Orthopaedics, Nanotechnology, Computational Material Science, Imaging etc.

Healthcare Leader - Tech Mahindra Development Center - Shanghai, China

(2012-10 - 2013-10)

• Lead Healthcare development; Technical supports for marketing and sales team
• Cooperate with Strategy and Solution departments to finish integral technique deliveries to customers
• Develop new businesses

R&D Consultant - Covidien (now Medtronic) medical technology Co.

• Entire endoscopic/gastrointestinal single use disposable/reusable MIS suture products (stapler) development cycle from conception to commercialization; Design and documentation; Prototyping; FEA; BOM; Human factor; Cleaning/Sterilization/Reprocessing method; Traceability matrix; CFD/Thermal; DFMEA; Design for Manufacturing (DFM); Product specification; Patent review
• Design and build testing system for functional testing and design change; Perform testing

Sr. Research Engineer - Stryker Orthopaedics, Advanced Technology - Suzhou, Jiangsu Province, China

(2011-02 - 2012-07)

• Conduct bone-device interaction and material analyses to effectively predict the short and long-term performance of next generation orthopaedic knee devices; CNC, CAPA, GMP

Postdoc Research Scientist - Columbia University, Department of Orthopedic Surgery - New York, NY

(2009-03 - 2010-03)

• Biomechanical research of total shoulder arthroplasty at the Sports Medicine and Biomechanics Lab
• FEA Modeling on shoulder implant structure, and planned physical testing (static, dynamic)

Postdoc Research Associate - Oakland University, Department of Physics and Center for Biomedical Research - Rochester, MI

(2008-07 - 2009-02)

• Perform research on cartilage at the Medical Physics and Imaging Lab
• Micro-indentation testing on cartilage, and comparing testing results with imaging tools
• Creating testing plan and report with statistical analysis

Research Assistant, Teaching Assistant, Consultant - University of Notre Dame, Aerospace and Mechanical Engineering Department - Notre Dame, IN

(2002-08 - 2008-07)

• Lead/Perform research on biomaterials/thin-film polymer in the Nano-Mechanical Characterization & Biomechanics Lab
• Perform large amounts of testing (nano-/micro-scale and bulk testing, DOE, statistical analysis) and finite element simulation of biomaterials

Ph.D. - Biomechanical Engineering - University of Notre Dame (2002 - 2007)

M.E. - Engineering Mechanics and Technology - Tongji University (1999 - 2002)

B.S. - Civil Engineering & Hydraulic Engineering - Shandong University (1994 - 1998)