Kirsten Linnabary Email & Phone Number

Raritan, NJ, US

Raritan, New Jersey, United States

• Served as interim Technical Lead on a New Product Development (NPD) project
• Developed Voice-of-Consumer (VOC) questionnaires to acquire surgeon customer feedback to support NPD activities
• Supported the development of manufacturing processes for novel STRATAFIX™ Spiral barbed sutures
• Established, performed, and documented test methods to determine the correct shipping configuration for global shipment of goods
• Lead the design, implementation, and documentation of competitor comparison testing

Rancho Santa Margarita, California, United States

• Led an investigation into insulation material choice for development of a new electromedical device
• Designed test protocols to assess material degradation and assign an appropriate device lifetime
• Modified new equipment & mechanical fixturing to help with manufacturing new products
• Examined the materials and assembly processes to identify common failure modes for an electromedical device to ensure proper functionality, usability, and safety
• Collaborated with team to develop and validate an original Usability Test Method
• Updated Risk Management documentation to comply with new EU medical device regulations

Rancho Santa Margarita, California

• Introduced new, large-output manufacturing processes into the production environment
• Managed team members on process improvement and documentation projects
• Improved various manufacturing processes to make the assembly of product easier and faster
• Developed bill of materials, part files, drawings, and inspection characteristics for new parts
• Updated design matrices for released models
• Completed validation and verification activities for new parts

Cincinnati, Ohio

• Mentored first-year students in a beginning coding course that taught Python, VBA, MATLAB, and LabView
• Evaluated students on projects and assignments
• Led class activities and discussions

Cincinnati, Ohio

• Supported a research study about the radiopaque characterization of magnesium stents
• Managed the inventory of research supplies

Parsippany, New Jersey

• Led the transfer of a manufacturing supplier as they moved production sites
• Compared local and corporate validation protocols to determine possible statistical disparities in procedures
• Generated supply chain maps for implantable raw materials
• Communicated with suppliers to ensure product quality
• Directed supplier onboarding and disengagement activities
• Managed various NCRs, CAPAs, and SCARs

Cincinnati, OH

• Created a fixture model in SolidWorks, 3D printed prototypes and assembled three fixtures now used in service operations
• Operated 3D scanners to reverse engineer infusion devices for analysis
• Verified designs by comparing drawings to manufactured parts
• Performed incoming quality assessments and completed inspection forms
• Finished final testing of outgoing finished product for shipment to customer
• Created a new operating procedure now used in assembly to increase efficiency

Cincinnati, OH

• Assisted a post-doctoral fellow with the preparation and screening of proteins to identify novel drug-like effects on mice in the molecular cardiovascular biology lab
• Collected data on various mouse muscles to determine the direction of research projects on the topic of muscular dystrophy
• Invited to continue in lab after the conclusion of summer commitment

Master Of Business And Science - Mbs, Business & Product Design

Bachelor'S Degree, Biomedical/Medical Engineering, Graduated Cum Laude

Activities and Societies: • Phi Sigma Rho • University Honors Program• Phi Sigma Rho: Vice President of Administration, Director of Sister.

High School Diploma/ Certificate Of Completion, Bioscience Technologies

Earned third place in Eastland-Fairfield’s Bioscience Technology Capstone Research Competition. The research project was on apple cider.

High School Diploma

Activities and Societies: Honor's Concert Band Marching Band Model United Nations