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Career

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Non-clinical and Clinical Engineering Support- Closed

📣 Apranik MedTech Consulting is hiring! 
We are looking for a highly skilled and motivated individual with a strong background in class II & III medical devices to provide non-clinical and clinical engineering support. The role involves leading performance testing of medical devices to demonstrate their efficacy, reliability, and safety in use. 
The current projects include simulated and physical bench performance testing, with potential future involvement in cadaver and in vivo models for procedural/device development. 

👉Key Responsibilities: â€‹

  • Develop test strategies and designs 

  • Establish acceptance criteria for tests 

  • Investigate bench models for procedural/device development 

  • Share clinical insights with cross-functional teams for device/procedure development or risk analysis 

  • Lead the creation of clinical documents (e.g., IFU, label claim substantiation) - Include references to Test Protocol and Reports of the Device in the documentation of 510k. 

👉Key Qualifications: â€‹

  • Preferably a master’s degree in engineering with 7+ years of direct experience (or bachelor’s degree with 10+ years of direct experience) 

  • Familiarity with standards and upcoming changes 

  • Capability to objectively assess a company's test protocols 

  • Experience with regulatory agency expectations of testing 

  • Testing experience with similar devices to assist in test setup and performance.

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Experienced Clinical Research Associate- Open

​📣 Apranik MedTech Consulting is growing, join us on our mission to drive healthcare forward!

👉Key Responsibilities: ​​

  • Perform site monitoring visits (selection, initiation, monitoring, and close-out visits) by the contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

  • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.

  • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.

  • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.

  • Ensure copies/originals (as required) of documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.

  • Create and maintain appropriate documentation regarding site management, monitoring visit findings, and action plans by submitting regular visit reports, and generating follow-up letters and other required study documentation.

  • Collaborate and liaise with study team members for project execution support as appropriate.

  • If applicable, may be accountable for supporting the development of the project subject recruitment plan on a per-site basis.

  • If applicable, may be accountable for site financial management according to an executed clinical trial agreement and retrieve invoices according to local requirements.​

👉Key Qualifications:​

  • You are based in the USA and do not require work visa sponsorship.

  • should have a related education and at least 10 years of CRA experience in medical devices.

  • You have experience of independent on-site monitoring experience.

  • You've handled multiple protocols and sites across a variety of medical device indications & classes.

  • Flexibility and ability to travel.

  • Attention to detail, diligent review of study & site documents.

  • Strong communication, written, and presentation skills.

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Senior Human Factors Consultant – Medical Devices (Remote)- Open

​📣 Apranik MedTech Consulting is growing, join us on our mission to drive healthcare forward!

👉Key Responsibilities: ​​

​      

  • Human Factors Strategy & Execution

  • Apply human factors engineering principles to improve the usability, safety, and effectiveness of a variety of medical devices.

  • Lead the development of human factors plans, user profiles, and use scenarios

  • Usability Testing

  • Design and execute formative and summative usability studies.

  • Analyze findings, generate insights, and provide actionable recommendations for design improvements.

  • Risk & Regulatory Compliance

  • Ensure all human factors activities align with regulatory requirements, including FDA Human Factors Guidance, ISO 14971 (risk management), and IEC 62366 (usability engineering).

  • Prepare and review documentation for regulatory submissions, including Human Factors Engineering Reports and Use-Related Risk Analyses.

  • User Research & Analysis

  • Conduct contextual inquiries, task analyses, and cognitive walkthroughs to inform user interface design decisions.

  • Stakeholder Collaboration

  • Work with cross-functional teams, including design, engineering, quality, and regulatory affairs, to integrate usability throughout the product development process.
     

👉Key Qualifications:​

  • You are based in the USA and do not require work visa sponsorship.

  • Minimum 10 years of experience in human factors engineering or usability testing within the medical device industry.

  • FDA Human Factors Guidance, IEC 62366 (Usability Engineering), ISO 14971 (Risk Management)

  • Bachelor’s or Master’s degree in Human Factors Engineering, Ergonomics, Psychology, Biomedical Engineering, or related field.

  • Strong communication, analytical, and documentation skills.

  • Ability to work independently and consult across a wide range of device types.

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