Clinician

At EPM, we are proud to be collaborating with a leading medical device company in the U.S. to drive innovation and improve patient outcomes. Our mission is to help revolutionize healthcare by advancing the development and evaluation of cutting-edge medical devices that make a real difference. As we continue to grow and make strides in clinical excellence, we are seeking a highly skilled Clinician to join our team and play a key role in the testing, evaluation, and clinical studies of these life-changing devices.

Position Overview:

We are seeking an experienced Clinician to support the development and clinical evaluation of medical devices in partnership with a prominent medical device manufacturer in the U.S. The ideal candidate will bring a combination of clinical expertise, hands-on experience with medical devices, and a passion for improving healthcare outcomes. The role involves working directly with the latest devices, clinical trials, and evaluation processes to ensure that our devices meet the highest standards of safety, efficacy, and usability.

Key Responsibilities:

• Clinical Evaluation & Study Support:
  • Participate in the design, execution, and analysis of clinical studies for innovative medical devices.
  • Work closely with cross-functional teams including R&D, regulatory affairs, and product management to ensure clinical trials align with medical device development timelines and regulatory requirements.
  • Provide valuable clinical insights to support the development and testing phases of medical devices.
  • Collect and analyze clinical data, ensuring adherence to protocol and reporting findings to relevant stakeholders.
• Clinical Device Testing:
  • Conduct hands-on testing and evaluation of medical devices in clinical settings.
  • Assess usability, safety, and effectiveness of devices during real-world clinical trials.
  • Support the development of clinical protocols and test plans that validate the performance of devices under various conditions.
• Regulatory & Compliance Support:
  • Ensure clinical evaluations are conducted in compliance with FDA, ISO, and GCP guidelines.
  • Assist with clinical documentation required for regulatory submissions and approvals.
• Training & Education:
  • Provide training to clinical sites and healthcare professionals on device protocols, usage, and safety features.
  • Serve as a clinical expert in meetings with internal teams and external stakeholders regarding device evaluation.
• Collaboration & Communication:
  • Collaborate with design, engineering, and regulatory teams to optimize device features and ensure user-centric development.
  • Communicate findings, recommendations, and concerns related to device performance and clinical safety.

Required Qualifications:

• Education:

  • Bachelor's degree in Nursing (BSN), Physician Assistant (PA), Medical Doctor (MD), or other relevant clinical healthcare fields.
  • Additional clinical certifications or advanced degrees (e.g., MSN, DNP) preferred.

• Experience:

  • Minimum of 2 years of experience in the use, development, testing, or clinical evaluation of medical devices, or in clinical trials related to medical device evaluation.
  • Familiarity with regulatory requirements such as FDA guidelines, ISO standards, and Good Clinical Practice (GCP).

• Skills & Competencies:

  • Strong understanding of medical device design, evaluation, and clinical trial processes.
  • Clinical experience in a hospital or clinical research setting with direct patient care or medical device usage.
  • Excellent verbal and written communication skills, with the ability to interpret and convey clinical data.
  • Ability to work well in a cross-functional, multidisciplinary team.
  • Proficiency in managing clinical trials, collecting data, and ensuring compliance with regulations.

Preferred Qualifications:

• Experience in conducting clinical trials or evaluating medical devices in a clinical or laboratory setting.
• Familiarity with post-market surveillance, product lifecycle management, or product improvement processes.
• Knowledge of emerging healthcare technologies and trends in medical devices.