Amanda Ojeda Email & Phone Number

Minneapolis, Mn, Us

Cerebral Spinal Fluid Management (Business Unit)

Kalamazoo, Mi, Us

• Led multiple engineering & supply chain teams across 5 global sites in the upgrade of 350+ products to comply with new EU MDR regulation while ensuring no customer or financial disruption to the business• Ensured timely completion of deliverables to divisional partners including technical documentation review, manufacturing flow chart generation, on-device product updates, & supplier change management• Defined & delivered against yearly program budget ($1.9M)• Identified & created new business processes for inventory management & global product distribution to mitigate compliance risk & $2.3M in product loss• Lobbied for, acquired funding, & led the development & validation of PowerBI dashboards with IT to improve data collection, transparency, & reporting of project metrics• Provided regular reports on project progress, metrics, & business impact assessments to senior leadership including hosting monthly divisional forums• Introduced & led the adoption of Agile methodologies among engineering team• SME to product & regulatory teams • Stryker WISE (Women in Science & Engineering) - Flower Mound Site Co-Lead

Kalamazoo, Mi, Us

• Collaborated with R&D, quality, & supply chain teams to re-design product packaging & establish defect correction process to address product damage during transportation & manufacturing leading to $1M annual savings• Stryker Women's Network - Flower Mound Steering Committee• Stryker WISE (Women in Science & Engineering) - Flower Mound Steering Committee

Kalamazoo, Mi, Us

• Analyzed and resolved production issues through collaboration with engineering, operations, and purchasing teams• Drove suppliers to provide root cause analysis and timely corrective action of nonconformances related to cosmetic, design, packaging, and material defects • Monitored statistical process data and analyzed trends, financial results, and customer feedback• Exhibited a commitment to quality, compliance and continuous improvement through the implementation of projects to optimize production, inspection, and quality system processes• Assisted with the development of risk assessments, PFMEAs, and risk mitigation activities• Led regular nonconformance root cause investigations and implemented corrective and preventative actions of issues such as labeling, testing, training, and work instruction deficiencies • Ran point on numerous ship holds, involving hosting daily team meetings and leading containment activities• Hosted monthly product improvement meetings to promote engineering collaboration on current and future products• Created, maintained, and reviewed technical drawings, inspection criteria, quality procedures, and device history records • Supported FDA, UL, and corporate audits and ensured compliance of processes to 21CFR820 and ISO13485 QSR• Assisted with integration activities related to Berchtold acquisition including training, testing, and procedure creation and test fixture validation• Certified ISO9001:2015 (inclusive of ISO13485:2016) lead auditor trained in Lean Six Sigma and human error investigation training• Awarded Employee of the Quarter, Q3 2018

Baltimore, Md, Us

• Collected clinical data related to ventricular assist devices (VAD) and assisted with database entry• Tested and maintained VAD equipment and assisted in monitoring of VAD patients

• Advised teams on projects, worked on internal development, assisted in conflict resolution, organized meetings and events, assisted in member and client selection• Recruited new members, team leaders, and executive board members, reviewed applications, interviewed applicants, coordinated social events, led marketing and advertising campaign • Improved operational management by mapping and refining work processes and surveying and interviewing employees of a government agency that provided housing and resources for the homeless • Developed a sustainable organizational structure modeled after similar institutional structures and centralized communication and company resources for an educational non-profit

• Reviewed and edited curriculum materials, maintained student account and educational records, and conducted data entry• Duties also included general office duties such as filing documents, creating educational resources, and providing information to supervisors and co-workers by telephone, e-mail, or in person

• Worked with a team of ten and a budget of $2500 for this internship run with the JHU Advertising and Integrated Marketing Communications course and serving MindSumo (an online service matching companies with candidates to solve business problems for a reward)• Organized the overall marketing strategy and managed the campaign logistics• Personally developed and implemented the interactions and events with the target market through two events: tabling at a lacrosse game tailgate and hosting an interactive activity day on campus called “Challenge a Sumo” that together yielded ~30% of the total goal of new users for the client• Tasks included ordering and coordinating resources, securing proper event authorizations, managing 10-20 event staff members, and interacting with hundreds of prospective users• Passed online JHU School of Public Health IRB Certification course in order to assist the Market Research Department

• Originally Biomedical Engineering Design Team• Worked with a team of seven undergraduates through the design, research, manufacturing, and testing process to develop an implant for stress urinary incontinence (patent pending)• Collaborated with clinicians and patients to receive design input and validation• Worked primarily on research, prototyping, and conducting animal testing at Johns Hopkins Hospital• Developed competitive business plans and presentations and presented them to faculty, physicians, and industry experts• Participated in ZeroTo510 Medical Device Accelerator Program to continue work on the device, apply for FDA clearance, and start up a medical device company in Memphis, TN (currently Urova Medical Inc.)

Bachelor Of Science (B.S.), Biomedical Engineering

High School Diploma