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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 within the medical device industry. Proficient in risk analysis, clinical performance evaluation, and regulatory compliance, with strong communication and interpersonal skills for effective collaboration with healthcare professionals.
Highest-signal resume keywords
Clinical KnowledgeRisk AnalysisRegulatory ComplianceCatheter Lab ExperienceStrong Writing Skills
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 EvaluationDevice Instructions For Use (IFU)Health Hazard AssessmentsTest Method DevelopmentFluoroscopy OperationScrub Technician ExperienceQuality System ComplianceProduct TestingIn-Vitro Device EvaluationIn-Vivo Device Evaluation
Soft Skills
Strong Verbal CommunicationInterpersonal SkillsJudgment for Problem ResolutionMentoring and Guidance
Tools & Technologies
Microsoft OfficePowerPointExcel
Certifications & Qualifications
RT CertificationRN CertificationRCIS Certification
Industry Keywords
Medical DeviceQuality SystemsRegulatory Approval ProcessesPatient SafetyProduct Development
About the role
Key responsibilities & impact- Provide clinical knowledge, expertise, and direction for 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 for new products by interacting 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 analyze potential patient risks
- Participate in the Product Action process by performing and documenting Health Hazard Assessments and communicating them to Quality Assurance
- Contribute clinical perspective to product recall and field action decisions
- Attend Product Action Committee meetings, summarize clinical feedback, perform product testing as needed, and provide clinical expertise
- Establish and cultivate a support network to complete assignments
- Develop less experienced staff through example, guidance, and counsel
- Participate in determining project goals and objectives
- Influence middle management on technical or business solutions
- Use judgment to select innovative, practical methods for problem resolution
Requirements
What you’ll need- Bachelor's degree plus 7+ years of related work experience, 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 experience ideal
- Solid understanding and application of business concepts, procedures, and practices
- Ability to work in a quality system environment and comply with governmental regulations
- Willingness to travel up to 30-50%, including internationally
- Strong writing skills for protocols and reports
- Strong verbal communication skills
- Interpersonal skills for 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, 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 for qualifying employees
- 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 and incentives
- Retirement plans
- Medical, dental, and vision programs
- Wellness and occupational health programs
- Paid time off
- 401(k) retirement savings with a generous company match
- Fast-paced work environment where safety is a priority