Ellen Bowman Email & Phone Number

Mansfield, MA, US

• Led team of 3 direct reports and 5 contractors supporting new product development projects across 5 new therapeutic and diagnostic catheter platforms.
• Managed portfolio of 9 cost savings projects representing savings of up to $7.5 MM per year.
• Influenced supply chain decisions made at the core team level to mitigate program risks and accelerate timelines; present decisions to the governance team as needed.
• Networked broadly within the BWI organization as the point person for all facets of NPD component development including supplier selection, qualification, and stabilization.

• Drove completion of deliverables for 13 new components on the Heliostar catheter while mitigating supply chain risks and strategizing how to meet challenging timelines.
• Oversaw strategic relationships with 5 key external manufacturing partners and established clear expectations to achieve business needs on time and within budget.
• Presented weekly updates to senior R&D and supply chain leaders on component readiness for all 51 new components critical to the Helios program.
• Identified opportunities to streamline the component development procedure and eliminate redundancies saving 10+ days of approval time per project.

Valencia, CA, US

• Managed R&D projects and 10-person team focused on the launch of a minimally invasive medical device startup company.
• Co-invented, designed, and supported end-to-end production of sensor substrates, fabrication processes, the insertion system, and testing and all accompanying documentation.
• Anticipated needs of company and developed standard operating procedures and plans to enable the team’s success and drive down risk identified by potential investors.
• Pitched Percusense to physicians and investors at the 2017 SoCalBio Conference and 2018 MedTech Innovator Startup Accelerator

Los Angeles, CA, US

• Relocated to new office obtained via acquisition to build relationships, bridge systems, resolve conflicts, and make time sensitive decisions.
• Communicated production engineering interests during weekly meetings of globally distributed leadership team and traveled as needed to accelerate collaboration.
• Liaised with international contract manufacturer regarding product architecture, technical requirements, and assembly instructions to support product transfer.

Los Angeles, CA, US

• Monitored completion of design team deliverables and communicated progress towards system completion at weekly core team meetings.
• Mentored nascent engineering team of five to develop operating procedures, design control, and quality documentation required by regulated hard-hat industry.

Minneapolis, MN, US

• Led mechanical engineering team through design, development, and commercialization of a next generation disposable glucose sensor and durable insertion device.
• Prepared comprehensive documentation for the Design History File (DHF) that was included in a high-visibility regulatory application for an investigational device exemption (IDE).
• Conducted gap analyses and instituted corrective actions and change orders as part of FDA 483 quality system remediation efforts.
• Visited clinician sites of key opinion leaders as needed to understand customer requirements and supported on-going pre-clinical, clinical, and pivotal studies.

Minneapolis, MN, US

• Wrote engineering specifications, assembly procedures, system level test reports, and change orders required to gain regulatory approval and ultimately launch a new glucose sensor product into the OUS market.
• Supported manufacturing transfer of glucose sensors from R&D pilot line to high volume production.
• Collaborated with cross-functional team to produce technical troubleshooting guides and glucose sensor demonstration kits for worldwide distribution.

Minneapolis, MN, US

• Characterized modes of device failures and correlated observations to in-vivo sensor performance.
• Created novel adhesive tape to keep glucose sensors in the body throughout 7-day wear period.
• Coordinated builds of 1,000+ sensors per week for benchtop, pre-clinical, and clinical evaluation.
• Implemented new assembly processes and completed nine related IQ/OQ/PQ validations.

B.S., Biomedical Mechanical Engineering

Master Of Business Administration - Mba