A Day in the Life
Responsibilities may include the following and other duties may be assigned.
- Provide key input into new product design as the clinical SME
- Ability to stress test and challenge ventilators in simulated use case scenarios leveraging clinical experience, analytic evaluation, creative troubleshooting, and creative problem-solving. Understanding all ventilator function compared to but not limited to ventilation waveform evaluations, simulated patient evaluations, test lungs, and bench testing. Analyze and generate reports for stress testing activities
- Participate in post data processing. Experience with mechanical test lung technology such as the ASL 5000 and Michigan Instruments TTL. Experience with digital data acquisition and analysis.
- Prepares, presentations for teams on clinical findings
- Contributes clinical expertise on a cross functional team to identify evidence needed to demonstrate safety and performance of new and existing devices, as well as provide clinical input into various internal and external product documentation. Such as input into new product development, MDR, CDP as the clinical SME.
- Oversees and interpret results of clinical investigations in preparation for new or existing devices.
- Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations and may prepare clinical trial budgets.
- People working within region/country may also have the responsibilities that include:
- Represents Medtronic from a clinical research respective within the country / region and also collects feedback from local customers and authorities.
- Builds and maintains optimal relationships and effective collaborations with various internal and external parties.
- Drives local evidence dissemination & awareness.
- Candidates are expected to have a deep knowledge in mechanical ventilation, respiratory care, design controls, quality assurance, regulatory affairs, and data analysis.
- Clinical expert in the design, development and creation of complex medical devices related to respiratory, critical care or general care floor products.
- Provide clinical perspective and support to guide new product development and/or post-market sustaining engineering core teams. May require ongoing core team support (e.g., weekly meetings) or periodic, as needed participation and input.
- Consult on matters affecting patient/product safety, design, testing, creation of high performing products, post market support, regulatory registration and clinical audit support.
- Advanced knowledge of assigned products and therapies including device design and function, hazards and harms, product labeling, indications for use, populations evaluated, diseases treated, mechanism of action, care pathways, and safety profiles.
- Gather input from external sources, marketing, R & D and other business stakeholders in order to ensure testing and registration activities accurately represent healthcare use scenarios.
- Collaborate with Quality and other cross-functional partners to develop comprehensive risk documentation, such as: Risk Management Plan, Product Risk Assessment, Design Failure Modes and Effects Analysis (FMEA), Software FMEA, Process FMEA, Risk Management Report, and Post Launch Risk Management Review.
- Provides input into the clinical strategy for post-market activities.
- Provides subject matter expertise to ensure on-time completion of CE documents such as CER, PMCFP/R, CERs, etc, to substantiate the safety and performance of assigned medical devices in order to support product launches or recertifications in various regions. (may require working with other internal or contract medical writers)
- Collaborate with Quality and other cross-functional partners to develop comprehensive risk documentation, such as: Risk Management Plan, Product Risk Assessment, Design Failure Modes and Effects Analysis (FMEA), Software FMEA, Process FMEA, Risk Management Report, and Post Launch Risk Management Review
- Perform periodic reviews of risk documentation and product labeling; ensure appropriate updates are implemented
- Participates in comprehensive literature searches to develop and maintain in-depth knowledge and understanding of current scientific literature required to support identified product lines and related clinical studies, staying informed about applicable clinical landscapes and trends
- Provide clinical perspective and support to guide new product development and/or post-market product sustainability for engineering core teams. May require ongoing core team support (e.g., weekly meetings) or periodic, as needed participation and input
- May participate in audits
- Consistently apply applicable global regulations and guidelines, as well as Medtronic policies and procedures.
Must Haves (Minimum Requirements):
To be considered for this role, the minimum requirements must be evident on your resume.
- Bachelor's degree and a minimum of 7 years of experience in Respiratory Therapy (Mechanical Ventilation - Critical Care, ECMO) /Clinical Research/Clinical Affairs, or advanced degree and a minimum of 5 years of experience in Respiratory Therapy (Mechanical Ventilation - Critical Care, ECMO)/Clinical Research/Clinical Affairs.