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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive clinical knowledge and expertise in medical device development, including performance evaluation, risk analysis, and regulatory compliance. Proficient in collaborating with cross-functional teams and providing clinical insights to enhance product safety and effectiveness.
Highest-signal resume keywords
Clinical Performance EvaluationRisk AnalysisMedical Device Quality SystemsCatheter Lab ExperienceRegulatory Product Approval Processes
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical KnowledgeDevice EvaluationHealth Hazard AssessmentProduct TestingWriting Instructions For UseTest Method DevelopmentFluoroscopy OperationScrub Technician ExperienceSimulated Catheter Lab TestingBusiness Concepts Application
Soft Skills
Strong Verbal CommunicationInterpersonal SkillsMentoringProblem SolvingInfluencing Skills
Tools & Technologies
Microsoft OfficeFluoroscopy Unit
Certifications & Qualifications
RT CertificationRN CertificationRCIS Certification
Industry Keywords
Quality System EnvironmentPatient SafetyProduct RecallClinical InputRegulatory Affairs
About the role
Key responsibilities & impact- Provide clinical knowledge, expertise and direction relevant to manufacturing, quality, performance and patient safety throughout product or concept development
- Support product development through clinical input to bench testing and in-vitro and/or in-vivo device evaluations
- Assist in developing new test methods to improve understanding of device performance
- Create clinical performance evaluation plans assessing physician acceptance and expected performance of new products
- Interact with physicians, engineers, clinical coordinators and regulatory affairs personnel
- Write device Instructions For Use (IFU)
- Participate in risk analysis for new or improved devices and identify and analyze potential patient risks
- Perform and document Health Hazard Assessments for the Product Action process and communicate findings to Quality Assurance
- Contribute clinical perspective to product recall or field action decisions
- Attend Product Action committee meetings, summarize clinical feedback and perform product testing as needed
- Establish and cultivate an extensive support network to complete assignments
- Develop less experienced staff through example, guidance and counsel
- Help determine project goals and objectives
- Influence middle management on technical or business solutions
- Select innovative and practical methods to resolve problems
Requirements
What you’ll need- Bachelor's degree plus 7+ years of related work experience with a strong understanding of the specified functional area, or an equivalent combination of education and work experience
- Certification in a related field or health industry with combined work experience may be considered
- RT, RN, or RCIS certification or degree
- 4-5 years of recent catheter lab experience; coronary and endovascular experience ideal
- Solid understanding and application of business concepts, procedures and practices
- Ability to perform the job in a quality system environment and comply with governmental regulations
- Willingness to travel up to 30-50%, including internationally
- Ability and willingness to learn new technical and clinical skill sets
- Simulated catheter lab product testing during product development
- Strong writing skills for protocols and reports
- Strong verbal communication skills
- Interpersonal skills interfacing with physicians
- Familiarity operating a fluoroscopy unit and working in a fluoroscopy/sterile environment
- Experience as a scrub technician during procedures
- Experience with medical device quality systems and/or regulatory product approval processes
- Experience with Microsoft Office products, including PowerPoint and Excel
Benefits
Comp & perks- Career development with an international company
- Free medical coverage in the Health Investment Plan (HIP) PPO medical plan (eligibility in the next calendar year)
- Excellent retirement savings plan with high employer contribution
- Tuition reimbursement
- Freedom 2 Save student debt program
- FreeU education benefit toward a bachelor’s degree
- Training and career development, including onboarding programs and tuition assistance
- Competitive compensation, incentives and retirement plans
- Medical, dental, vision, wellness and occupational health programs
- Paid time off
- 401(k) retirement savings with a generous company match