Specialist, Clinical Development

Edwards Lifesciences Gruppe; Irvine (CA); On-site; USD 87,000 - 123,000; Full time

Job summary

Edwards Lifesciences Irvine is seeking a Clinical Affairs/Engineering role focused on transcatheter heart valve development. You will guide pre-clinical strategies, support first-in-man evaluations, and provide clinical rationale for product attributes to ensure patient safety and physician usability.

The position involves creating and updating clinical risk assessments, design controls, and documentation to meet GLP/GCP standards, while collaborating across cross-functional teams and regulatory

Qualifications

• Bachelor's Degree in biological or Life sciences field.
• 3 years' experience in Class II/III medical device technologies and/or clinical studies.

Responsibilities

• Develop pre-clinical test strategy and guide execution.
• Design and conduct first-in-man evaluations with case support.
• Provide clinical briefs and literature rationales for device attributes.
• Prepare and update clinical risk assessments and design validation reports.
• Coordinate literature searches for design concepts and clinical evaluation reports.
• Collaborate with field trial managers to gather performance feedback and ensure regulatory compliance.

Skills

MS Office

Adobe

Ignite

Clinical studies

Medical device regulations

Communication

Problem solving

Education

Bachelor's in biological/Life sciences

Bachelor's in engineering

Tools

Ignite

Job description

We’re dedicated to pioneering next-generation innovations for patients with aortic regurgitation (AR). Our Transcatheter Heart Valve (THV) business unit brings together Clinical Affairs, Engineering, and Research professionals to design and develop minimally invasive therapies that impact patient outcomes and quality of life. We’re working together to transform cardiovascular care and device development to address unmet patient needs in structural heart disease. Join us and be part of our inspiring journey.How you'll make an impact:Ensures product development includes all necessary clinical input and aspects for the best interest of patients and utility for treating physicians.Ensure successful product lifecycle management for multiple projects, including:Develop and implement pre-clinical test strategy and provide guidance to team members on strategy executionDesign, prepare and conduct first-in-man product evaluations, including case support for proper product useCreate Clinical Investigator BrochureProvide scientific rationale for product attributes and pre-clinical test results to regional clinical teams necessary to obtain site and country approvalsProvide product expertise for new product introduction training for clinical and site personnelDesign, develop, conduct, and assess results of post-market evaluationsDevelop, review, and update clinical design control documents including technical summaries, clinical risk assessments, design of validation protocols and reports, design and application of FMEAs (Failure Modes and Effects Analysis), for technical and clinical documentation in moderately complex product development.Ensure medical and scientific factors are considered during cross-functional product development project team meetings.Design, review and/or conduct literature searches and complete literature reviews for design concept, product development, protocol preparation, clinical risk assessments and/or clinical evaluation reports.Evaluate collected data documentation and imaging media, draw findings, and make recommendations to complete product evaluations, product complaint review and other required interim or final reports.Consult with field trial managers to gather field device performance feedback, as well as to ensure national and country clinical/regulatory requirements compliance.What you'll need (required):Bachelor's Degree in biological or Lifesciences field3 years previous related experience in Class II and III medical device technologies and/or clinical studies backgroundWhat else we look for (preferred):Bachelor's Degree in engineeringProven expertise in MS Office Suite, Adobe, and ability to operate general office machineryExperience with documentation management systems (e.g., Ignite)Excellent written and verbal communication skills and interpersonal relationship skillsDemonstrated problem-solving and critical thinking skillsModerate knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical studiesModerate understanding of pre-clinical testing protocols, hospital environments and sterile techniquesModerate knowledge of US and international medical device regulations, of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)Ability to manage confidential information with discretionStrict attention to detailAbility to interact professionally with all organizational levelsAbility to manage competing priorities in a fast paced environmentAbility to work in a team environment, including inter-departmental teams and representing the organization on specific projectsAbility to build productive internal/external working relationshipsAdhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/controlAligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.For California (CA), the base pay range for this position is $87,000 to $123,000 (highly experienced).The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.