Senior Clinical Systems Engineer
MedtronicAbout the role
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
This Senior Clinical Systems Engineer position will support the Clinical Engineering team and be a key member of the Systems Center of Excellence working to advance the technology and indications for a Robotic Assisted Surgical system.Clinical Engineering links Research and Development to the clinical setting by working closely with engineers and clinicians from pre-concept, through product development, to commercialization. We bring in-depth procedural knowledge of the clinical environment and collaborate with clinicians and cross-functional R&D teams in the design process. Combined, we define and develop the function of products within the robotic platform to ultimately improve outcomes for the patient. Clinical Engineering input primarily contributes to the User Needs, Clinical Acceptability Criteria for Requirements, Use Conditions, and Clinical Workflow definition as well as post market follow-up, integrating products into robotic clinical applications.
This role will involve working closely with our team of Clinical Systems Engineers to deeply investigate and represent current and future clinical applications of our device to both internal and external audiences. This position will focus on procedural research to support indications and instrument portfolio expansion, usage analysis, complaint investigation, regulatory submission support, and system configuration development.
Responsibilities may include the following and other duties may be assigned
Clinical Expertise
o Apply knowledge of the operating room environment and of medical technology to serve as an expert within the business on the clinical application of its products
o Perform procedural research on current and future indications and instrumentation, proposing novel ways of translating clinical needs to the project deliverables
o Maintain awareness of clinical applications of MDT Surgical Robotics products, transferring product knowledge to the larger team as part of product development and commercialization activities.
Product Development Process
o Pre-PDP / Opportunity: anticipating patient and customer needs through voice of stakeholder interviews, procedural research, and case observations
o Clinical Product Definition: translating user needs to customer / clinical requirements and identifying relevant use conditions / clinical acceptability values for requirements
o Product Development: represent clinical setting, clinician, and patient throughout development process, including support of rapid user feedback sessions and formal user study evaluations.
Clinical Implementation
o Develop system specific setups to enable end-users to access different anatomical workspaces and/or to perform complex procedures
o Drive customer- and patient-centric product vision to ensure successful integration with existing clinical workflows
o Analyze user feedback and provide clinical input to greater systems engineering organization
o Support clinical evaluation of new, existing, or enhanced products at customer sites.
Clinician Engagement
o Work with Key Opinion Leaders to gain clinical knowledge and translate user or clinical needs to engineering development teams
o Partner with clinical and non-clinical stakeholders to evaluate and expand Robotic Surgical Technologies program
o Support customer visits, conference customer engagement sessions, and clinical advisory board activities as needed.
Cross-Functional Clinical Input
o Support engineering regarding clinical risks and mitigations
o Support FDA / regulatory documentation and applications
o Support complaint handling and investigation as it pertains to clinical use, workspace access, and conversions
Must Have: Minimum Requirements
- Bachelor’s Degree with 4 years of relevant experience, or a Master's Degree with 2 years of relevant experience.
Nice to Have
- Engineering Degree in Biomedical, Robotic, or another applicable life sciences field.
- 0-3 years of medical / clinical experience (i.e. OR tech, nurse, PA, medical device sales rep)
- Working knowledge of human anatomy; preferred experience with surgical terminology and minimally invasive products
- Experience with statistical tools (JMP, Minitab, MatLab)
- Solid problem solving and analytical skills, whi
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