Susannah Chance Email & Phone Number

Austin, Texas, United States

Experienced Medical Device Professional with a focus on Project Management and Development.

Austin, TX

Project Lead for multiple, complex projects strategic for the Smith & Nephew ENT franchise.

Austin, TX

-Development Engineer leading Knee Remediation Teams to bring Legacy Design History File documentation to current standards; critical member of Design History File Remediation Effort, focused on Design Control document remediation. Coordinated cross-functional resources and deliverables. Supervised workload of 5+ contract development engineers..

• Designed and led project team for lumbar interbody line extension. Project consisted of in-between implant sizes in addition to instrument tray reconfiguration, additional trials, and establishment of shorter.
• Designed and led project team for transition pedicle screw re-design of fusion to dynamic segments, focusing on international market requirements and compatibility with existing implants and instruments.
• Led engineering investigation of device failure modes, including completion of verification protocols and reports along with CAPA root cause analysis.
• Assisted in design control completion for a new minimally-invasive pedicle screw system.
• Participated in multiple surgeon meetings, web conferences, and cadaver labs regarding a large scale pedicle screw system.
• Provided feedback to consultants for new design control system during implementation. Worked with consultants to develop practical applications of the new design controls.

• Managed the logistics of an 800+ SKU PS Knee System including instrumentation; Managed cross-functional team members to progress manufacturing, quality, procurement and regulatory tasks as needed for product launch..
• Responsible for all implant models and prints, both catalogue and in-process. Worked closely with manufacturing engineer, casting vendor, and machining house to develop specifications for component fabrication.
• Investigated product complaints to improve existing products as well as satisfy regulatory requirements for continuous sale of product.
• Communicated directly with surgeons to develop design inputs for special instrumentation; completed Risk Analyses for special instrumentation to ensure safe and effective devices were provided to end user.
• Regularly attended surgeries and cadaver labs to provide support to existing customers and continue my education of the medical device industry.

• Lead and managed a new project for knee implants and instruments to satisfy a market recently untapped by the company. Analyzed the mechanics of a licensed design to expand and improve upon the system to surpass other.
• Developed an Instrument Upgrade for the EPIK Uni-compartmental Knee including Verification, Validation, and Manufacturing Transfer, which has allowed Encore to achieve a greater portion of the market share. New.
• Completed Manufacturer of Record Transfer for an acquired product line from OTI, including documentation and drafting transfers to incorporate into the Encore Quality System. Additionally, worked diligently to develop.
• Delegated drafting and documentation requests to drafters and co-op students based upon capability and resource constraints.
• Designed improvements to the 3D Knee System for tibial downsizing capabilities as well as femoral impaction instrumentation to meet international requests for a clearer and less complicated surgery.
• Participated in FDA Audit to review and defend product complaint investigations as well as give direction to QA personnel regarding design control documentation.