Main Responsibilities and Required Skills for a Biomedical Engineer

Biomedical environment

A Biomedical Engineer is a professional who combines engineering principles with medical and biological sciences to design, develop, and maintain medical equipment and devices. They play a crucial role in improving healthcare technology and patient care. In this blog post, we will explore the primary responsibilities and the most in-demand hard and soft skills for Biomedical Engineers.

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Main Responsibilities of a Biomedical Engineer

The following list describes the typical responsibilities of a Biomedical Engineer:

Aid in

Aid in the assembly of prototypes and debug issues on the fly.

Analyze

  • Analyze and interpret data from medical equipment to assess performance and identify areas for improvement.

  • Analyze manufacturing performance through data review and analyses.

Approve

  • Approve designs, test protocols, and reports.

  • Approve test protocols and reports.

Assist in

  • Assist in defining and implementing performance evaluations.

  • Assist in the development of service contract specifications with external suppliers.

  • Assist in the development of the company's Quality Management System.

  • Assist the Regional Engineering Team Manager with strategic planning.

  • Assist with project planning and justification.

  • Assist with regulatory Submissions including 510 (k) s and CE Marking.

Brainstorm

Brainstorm to find solutions to scientific problems.

Collaborate with

  • Collaborate with clinicians to integrate medical devices into patient care processes.

  • Collaborate with healthcare professionals to identify their needs and challenges.

  • Collaborate with interdisciplinary teams to solve complex healthcare problems.

  • Collaborate with manufacturing teams for production and quality control.

  • Collaborate with outside patent counsel on more formal IP research.

  • Collaborate with process development on studies to determine root cause for deviations.

  • Collaborate with regulatory bodies to ensure compliance with medical device regulations.

Collect

Collect and analyze data using sensors and data acquisition cards.

Complete

Complete FMEAs and Risk Analysis for new and revised products.

Conduct

  • Conduct briefings with team members within job function.

  • Conduct business development research and due diligence activities.

  • Conduct feasibility studies for new medical device development.

  • Conduct research and experiments to improve medical technologies.

  • Conduct research and publish as appropriate.

  • Conduct research and technical assessments.

  • Conduct research on biomaterials and their applications in medical devices.

  • Conduct risk assessments and implement mitigation strategies.

  • Conduct troubleshooting and repairs of medical equipment.

  • Conduct usability studies and gather feedback from end-users.

Contribute to

Contribute to realization for new sensing modalities, membrane stacks, and processes.

Coordinate

Coordinate the medical equipment management program.

Create

  • Create and execute product test protocols.

  • Create and maintain BOMs and drawings for all Extension Sets.

  • Create assembly drawings for products as required according to SOP.

  • Create Bill of Materials (BOM) for new products and maintain existing BOMs.

  • Create prototypes and perform testing to validate product performance.

Design

  • Design and develop medical devices and equipment.

  • Design test fixtures or components.

Develop

  • Develop and implement maintenance and calibration protocols for medical devices.

  • Develop and maintain partnerships with external partners.

  • Develop design concepts and ideas for new products and product improvements.

  • Develop design inputs with associated justification for new product development.

  • Develop engineering prototypes of design concepts.

  • Develop engineering prototypes of design for engineering testing and evaluation.

  • Develop project plans and budgets.

  • Develop prototypes of design.

  • Develop prototypes of design concepts for engineering testing and evaluation.

  • Develop software applications and algorithms for medical data analysis.

Document

Document laboratory testing protocols and results as per corporate policies.

Draft

Draft invention disclosures.

Engage

Engage with clinicians and researchers to define clinical needs and uncover insights.

Enjoy

Enjoy developing and debugging mixed-signal hardware.

Ensure

  • Ensure compliance to all company policies / practices including ISO, Health and Safety etc..

  • Ensure compliance with safety regulations and quality standards.

  • Ensure that designs meet applicable standards and requirements (UL / CSA, IEC, ISO, etc.).

  • Ensure that network security issues are managed effectively for medical systems.

  • Ensure that standards of performance are defined and adhered to.

  • Ensure the proper operation and safe use of the equipment under your responsibility.

Establish

  • Establish and maintain data repositories.

  • Establish and optimize test methods and protocols for studies.

Evaluate

  • Evaluate and maintain process layout charts for all assembly processes.

  • Evaluate the economic feasibility of medical equipment and devices.

  • Evaluate the effectiveness and efficiency of medical equipment and suggest enhancements.

  • Evaluate the impact of new technologies on healthcare delivery.

Execute

  • Execute studies including the development of bench top, simulated tissue and wet lab studies.

  • Execute studies to demonstrate equipment fit and process performance.

Identify

Identify business and technical risks, gaps and opportunities effecting the 'Go-Live' event.

Implement

  • Implement codes in LabView / Matlab / Python, etc.

  • Implement mechanical designs for 3D printing and simulations.

Initiate

  • Initiate Change Controls for new and changes to existing products.

  • Initiate protocols for process evaluation.

Interact with

Interact with doctors and patients for collection and transcription of data.

Investigate

Investigate product complaints through sample evaluations.

Justify

Justify new product development and develop project plans and budgets.

Lead

  • Lead cross functional troubleshooting and operational improvements for manufacturing equipment.

  • Lead risk analysis activities.

  • Lead risk analysis and risk management activities including human factors studies.

Liaise with

Liaise with vendors and manufacturers.

Maintain

  • Maintain and ensure DHF's are updated according to regulatory requirements.

  • Maintain current awareness of literature and emerging approaches and methods in diabetes therapy.

  • Maintain knowledge of healthcare policies and regulations.

  • Maintain the database, including production data, waste data, and set-up data.

Mentor

  • Mentor junior associates, when applicable.

  • Mentor team members or subordinate supervisors, providing tactical and / or technical leadership.

Modify

Modify and customize existing medical equipment to meet specific requirements.

Optimize

Optimize medical equipment for efficient workflow and patient safety.

Oversee

Oversee the Recall and Alerts program for PVAMC's medical equipment.

Participate in

  • Participate in clinical trials and studies to evaluate the safety and efficacy of medical devices.

  • Participate in quality improvement projects as required.

  • Participate in the acquisition and evaluation of equipment as well as their obsolescence.

  • Participate on new product design projects and modifications to existing products.

Perform

  • Perform bio-medical / mechanical engineering, design, and development work.

  • Perform biomedical / mechanical engineering, design, and development work.

  • Perform engineering testing.

  • Perform human factors (usability studies) , market assessment, or pre-clinical research.

  • Perform or oversees biomedical / mechanical engineering, design, and development work.

  • Perform other related duties as assigned.

  • Perform preventive and corrective maintenance on biomedical equipment.

  • Perform research in market assessment or clinical and user studies.

  • Perform risk analysis and develop strategies for device failure prevention.

Prepare

Prepare project planning and pre-procurement documentation for medical equipment.

Provide

  • Provide expertise in medical imaging technologies such as MRI and CT scanners.

  • Provide for the application of medical devices during Minimally Invasive.

  • Provide high-level guidance to the Lead Engineer.

  • Provide quality of deliverables and demonstrates self-motivation to deliver.

  • Provide support to the Technical Services team as part of automated building management (BAS).

  • Provide task-level assistance to the Lead Engineer as necessary to fill technical resource gaps.

  • Provide technical expertise to the organization's managers and service personnel.

  • Provide technical support and training to healthcare professionals on medical equipment usage.

Research

Research or Commercial Experience in system modelling and algorithms for VSM applications.

Respond to

Respond to requests for service and assistance with professionalism, courtesy, and confidence.

Review

  • Review design and engineering drawings.

  • Review the general patent landscape to discover issues potentially affecting design.

Stay informed about

  • Stay informed about ethical considerations related to biomedical engineering.

  • Stay updated with advancements in medical technology and industry trends.

Train

Train technical and clinical staff on specific subjects as needed.

Travel

Travel to other sites or throughout the province is required.

Use

Use standard theories, principles and concepts and integrates them to propose a course of action.

Work with

  • Work collaboratively with Resource and Project Managers in meeting client needs.

  • Work in cleanrooms for laboratory experimentation and manufacturing.

  • Work on substantive projects that have the potential to impact the future business of the company.

  • Work under minimal supervision.

  • Work with Business Development to explore acquisition or partnership opportunities.

  • Work with fellow engineers and technicians to execute experimental designs.

  • Work with Regulatory to develop strategy for product submissions and approvals.

  • Work with technicians to prototype device concepts.

Write

  • Write scientific reports and proposals.

  • Write SOPs, test protocols and laboratory research reports as needed.

  • Write technical reports and documentation for regulatory compliance.

  • Write test protocols and reports.

  • Write test protocols, perform engineering testing, and write reports.

Most In-demand Hard Skills

The following list describes the most required technical skills of a Biomedical Engineer:

  1. Proficiency in programming languages such as MATLAB, Python, or C++ for data analysis and software development.

  2. Knowledge of medical device regulations and standards, including FDA regulations and ISO 13485.

  3. Expertise in medical imaging technologies, such as MRI, CT scans, ultrasound, and their image processing techniques.

  4. Understanding of biomaterials and their properties for developing biocompatible and safe medical devices.

  5. Familiarity with CAD software, such as SolidWorks or AutoCAD, for device design and modeling.

  6. Proficiency in signal processing and analysis techniques for biomedical signal acquisition and analysis.

  7. Knowledge of electronics and instrumentation for designing and troubleshooting medical devices.

  8. Understanding of medical device testing and validation processes to ensure safety and effectiveness.

  9. Experience with 3D printing and rapid prototyping techniques for device fabrication.

  10. Competence in using simulation software, such as COMSOL or ANSYS, for device performance evaluation.

  11. Familiarity with medical device connectivity, wireless communication, and IoT technologies.

  12. Knowledge of biomedical sensor technologies, such as biosensors or wearable sensors.

  13. Understanding of regulatory documentation and submission processes for medical devices.

  14. Proficiency in using statistical analysis software, such as SPSS or R, for data analysis and interpretation.

  15. Knowledge of bioinformatics tools and databases for genomic and proteomic data analysis.

  16. Expertise in biomedical optics and laser applications in medical diagnostics and treatments.

  17. Understanding of electrical safety standards and electromagnetic compatibility in medical devices.

  18. Experience in conducting usability studies and applying human factors engineering principles to device design.

  19. Knowledge of medical device software validation and cybersecurity principles.

  20. Proficiency in using simulation and modeling tools, such as Finite Element Analysis (FEA) software, for device performance evaluation and optimization.

Most In-demand Soft Skills

The following list describes the most required soft skills of a Biomedical Engineer:

  1. Excellent communication skills to collaborate effectively with healthcare professionals, engineers, and other stakeholders.

  2. Critical thinking and problem-solving abilities to analyze complex healthcare challenges and develop innovative solutions.

  3. Attention to detail to ensure accuracy and precision in device design, testing, and documentation.

  4. Strong analytical skills to interpret data, analyze results, and draw meaningful conclusions.

  5. Project management skills to oversee device development projects, meet deadlines, and manage resources effectively.

  6. Adaptability and flexibility to navigate evolving technologies, industry regulations, and healthcare practices.

  7. Teamwork and collaboration skills to work effectively in interdisciplinary teams and contribute to collective goals.

  8. Ethical conduct and professionalism in handling sensitive patient data and adhering to healthcare regulations.

  9. Continuous learning mindset to stay updated with the latest advancements in biomedical engineering and related fields.

  10. Time management and organizational skills to prioritize tasks, meet project milestones, and manage multiple projects simultaneously.

Conclusion

Te role of a Biomedical Engineer is multidimensional, encompassing technical expertise, research acumen, and the ability to collaborate effectively. By possessing the right combination of hard and soft skills, Biomedical Engineers can make significant contributions to the development and advancement of medical technology, ultimately improving patient care and outcomes.

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