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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 product development, quality assurance, and patient safety, with a strong focus on device performance evaluation and regulatory compliance. Proven ability to collaborate with cross-functional teams and mentor less experienced staff while effectively communicating clinical insights.
Highest-signal resume keywords
Clinical KnowledgeDevice Performance EvaluationMedical Device Quality SystemsRT, RN, or RCIS CertificationCatheter Lab Experience
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 Performance EvaluationHealth Hazard AssessmentProduct TestingTest Method DevelopmentRegulatory ComplianceFluoroscopy OperationSimulated Catheter Lab TestingWriting Protocols and ReportsRisk AnalysisQuality System Environment
Soft Skills
Strong Verbal CommunicationInterpersonal SkillsMentoringProblem SolvingInfluencing Middle Management
Tools & Technologies
Microsoft OfficePowerPointExcelFluoroscopy Unit
Certifications & Qualifications
RT CertificationRN CertificationRCIS Certification
Industry Keywords
Product DevelopmentPatient SafetyQuality AssuranceRegulatory AffairsCatheter Lab
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 during 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, perform product testing as needed, and provide clinical expertise
- Establish and cultivate an extensive support network to complete assignments
- Develop less experienced staff by setting an example, providing guidance, and offering 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 may be considered with combined work experience
- RT, RN, or RCIS certification or degree
- 4-5 years of recent catheter lab experience (coronary and endovascular 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
- Demonstrated ability and willingness to learn new technical and clinical skill sets
- Experience with 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)
- 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 and incentives
- Medical, dental, vision, wellness, and occupational health programs
- Paid time off
- 401(k) retirement savings with a generous company match