Oliver Bloom Email & Phone Number

Warsaw, Indiana, Us

Warsaw, Indiana, Us

Warsaw, Indiana, Us

• Promoted to manager due to successful implementation and project management of various large scale projects within the quality management system (QMS)• Lead a team of a dozen quality engineers and technicians in ten business units including raw material processing, manufacturing and distribution, to ensure medical devices meet all quality standards• Mentored new team members and quality co-ops/interns by using interpersonal skills to develop college students into successful engineers which resulted in team members being offered full time positions within the company• Managed corrective and preventative action (CAPA) projects in various areas of production and process control to ensure compliance to applicable regulatory standards resulting in all CAPAs closing as effective• Managed audit front room activities for internal and external quality system audits resulting no major audit findings from the leadership

Warsaw, Indiana, Us

• Developed into the SME for the nonconforming product process for Warsaw, Indiana (corporate headquarters) by designing the process which is used at four manufacturing sites globally• Redesigned the nonconforming product process and software system in response to an internal audit to streamline the process and ensure compliance with FDA and ISO standards• Managed a team of quality engineers to implement a new nonconformance process, updating 200 work instructions• Led a team of quality engineers and technicians in the validated process monitoring group to support daily operations• Directed four FDA 483 observation CAPAs, as lead in remediation efforts and corrective actions in areas of software validation, nonconforming product, validated process monitoring and field actions

Warsaw, Indiana, Us

• Managed the quality system of eight manufacturing cells including raw material management, metal machining, blasting, polishing, vacuum furnace bonding, cleaning and sterile packaging• Developed system logic, user requirements and software validation strategy for custom quality system software, successfully responding to a FDA 483 observation• Analyzed impact to product from out of tolerance gauges, performed hold rack reviews and product investigations

• Started company around creation of medical device, SnugLit, for treatment of infant jaundice• Developed a low cost functional prototype which will improve conventional treatment methods, suitable for commercial production for use in hospitals and home care settings throughout the nation• Developed a business plan to take SnugLit to market• Received $150,000 in seed funding from Quantum Medical Products to prepare for 510(k) submission• Visited several Michigan hospitals to receive design feedback and understand user needs• Won 1st place at The Hatching and Launched business model competitions for companies in the Lansing, MI area• Won undergraduate 2nd place at Greenlight Michigan Business Model Competition out of 98 applicants• Won 4th place at the International Business Model Competition at BYU out of 2500 teams• Selected as a top 3 finalist in Project Startup Live pitch competition on A&E network• Selected as a finalist in the Michigan Innovation Prize Competition out of 29 teams

Flint, Mi, Us

• Co-authored a study (A model to evaluate Pauwels type III femoral neck fractures) published in the Journal of Engineering in Medicine based upon completed project work• Worked on several orthopedic projects in the Bioengineering Applications Research Studio• Completed comprehensive literature reviews of three different projects• Wrote and submitted IRB and RAB applications for a cervical spine traction project at McLaren Hospital • Designed and built a fixture for securing and cutting model bone femurs• Designed and built drilling guides for three screw constructs in femoral neck fracture repair• Designed a fixture securing model femur bones during mechanical testing

• Learned how to translate clinical needs to design criteria and new innovative medical devices• Collaborated with a team of peers to develop a solution to improve CPR technique and patient outcomes• Developed a functional prototype to monitor patient vitals and provide real-time CPR feedback to rescuer • Competed in the Solve it Make it competition to secure funding for further product development• Developed a comprehensive design history file to ensure FDA approval for product commercialization• Selected to represent the University of Michigan in the nationwide BMEidea competition

• Developed knowledge of electrical medical device design and testing• Developed a low cost prototype to objectively determine efficacy of ADHD medications• Used EEG technology to measure brain wave activity and determine the degree of concentration• Investigated the impact of several stimuli on the ability of focus on a single task

• Supported execution of large triathlons across Michigan for athletes of all ages• Streamlined the setup required on race day in order to improve customer experience• Registered and assisted athletes to provide the best race day experience

Master Of Business Administration - Mba

Master Of Science, Biomedical Engineering, Medical Product Development

Bachelor Of Science, Biosystems Engineering; Biomedical Engineering