Project Engineer - Hemodynamic Pump Development
The Hemodynamic Pump Development Project Engineer at CSI is a broad and dynamic role that spans developing company long range strategy to assisting with the daily execution of product development and commercialization activities and programs for a percutaneous hemodynamic pump. The role has direct deliverable and material responsibilities over CSI’s hemodynamic pump development program.
With the cross department pump development team, the individual will be responsible for deploying aspects necessary to successfully execute CSI’s product plan, share in identifying and implementing industry best practices, share all prior knowledge and deployment activities in this space, create and scale robust processes and ultimately developing products that meet or exceed customer requirements for quality, safety and effectiveness, to offer an attractive business model for CSI. This role requires a proven track record of delivering a fully developed hemodynamic pump to market or iteration of such device to market.
This role requires interaction and collaboration with a broad set of stakeholders, including directors and executives throughout the organization, physician customers and key opinion leaders in the space, CROs, regulatory bodies, external suppliers, consultants and labs, OEM partners and service providers.
It is expected that this individual will be able to work effectively with existing resources while quickly identifying gaps and sourcing resources (internal or external) to mitigate gaps and minimize risk to the program
Other Essential Duties and Responsibilities:
- Drive collaboration within cross-functional partners from Engineering, Marketing, Manufacturing, Quality, Regulatory and other outside organizations as necessary
- Drive effective collaboration with external partners where needed
- Working multi geographic – Japan, EU, US – regulatory requirements, clinical support, physician partners
- The ability to travel up to 15%, including international
Knowledge, Skills and Abilities Required for Successful Job Performance:
- Education and/or Experience:
- BS in relevant engineering or science discipline, with advanced technical degree focused on an applicable specialization related to MCS (mechanical circulatory support) devices
- 10+ years of relevant medical device design and development experience, hemodynamic pump experience required, preferably temporary percutaneously delivered pumps. Balloon pump experience is helpful but not equivalent
- Self-motivation and initiative to prioritize work and otherwise perform the job with minimal supervision
- Conveys a sense of urgency and drives issues to closure
- Must be able to convey complicated topics and issues in a straight forward and concise manner, and be able to tailor communication style to the audience
- Ability to influence business unit leaders, with deep industry knowledge, direct past experience in the field, market insights, clinical insights, and effective communication
- Experience with medical device product lifecycle management over multiple releases, knowledge of workstreams and paths for subsequent approvals.
- Demonstrate understanding of business drivers, customer needs and global dynamics to create
- Direct experience identifying and sourcing components through known supplier network for commercial products.
- Direct experience and knowledge identifying and bringing on line test methods, procedures, and submission materials.
- Direct experience and knowledge with FIM studies and requirements, including but not limited to bringing electromechanical device into an EFS in the US.
- Risk management requirements and compromises for temporary hemodynamic pump programs, devices, and systems.
- Understanding of global regulatory requirements for medical devices; risk and reliability concepts for development; and the need to deliver quality products and/or processes
- Experience bringing CFD data to various regulatory and notified bodies for approval.
- Expert in current domain, and knowledgeable in policies, practices, trends, technology, and information affecting his/her industry, business and organization
- Become proficient in and demonstrate ability to understand the major data sources (clinical trials, studies, published reports, etc.) relative to the use of hemodynamic pumps
- Proven track record and knowledge of multi country labeling requirements, including iFU’s and product labeling.
- Proven record in hemodynamic understanding. Published peer reviewed materials, active member of organizations in this field (e.g. asaio, 14708 committee, artificial heart of MCS steering committees)
- Direct knowledge of manufacturing processes related to temporary but long duration (24+ hours) hemodynamic pumps, catheters, and introducers.
CSI is an EEO/AA company: Women, Minorities, the Disabled and Veterans are encouraged to apply. If you are a job seeker with a disability and require accessibility assistance or reasonable accommodation to apply for an open position, please contact the Recruiting Department at Cardiovascular Systems, Inc., 1225 Old Hwy 8, New Brighton MN 55112, or call (651) 259-1600.