Research And Development Engineer

3 days ago

Gaithersburg, United States Elutia Full time

Position Overview:


The R&D Engineer at Elutia is responsible for designing and developing biological-based medical devices, specializing in drug/device combination products according to industry standards. This role encompasses overseeing the entire development process, from initial concept through to commercialization. The R&D Engineer leads prototype and pilot production, develops and executes test methods, and collaborates with cross-functional teams to advance Elutia's product pipeline. They ensure seamless product development and facilitate tech transfer for successful clinical and commercial use by applying critical thinking skills to solve technical issues. Additionally, the R&D Engineer contributes to the intellectual property portfolio and ensures compliance with regulatory requirements to gain product approvals and support product lifecycle management.


The successful candidate will work onsite at the Company’s Gaithersburg, MD facility


Essential Duties & Responsibilities

  • Designing and characterizing biological matrices (decellularized ECM, collage, polymer) and drug/device combination products according to industry standards.
  • Developing drug coating and alternative drug delivery methods for sustained or extended release products.
  • Developing and executing test methods to support exploratory research and introduce new techniques.
  • Supporting prototype and pilot production of new products in collaboration with Manufacturing and Quality Control Systems.
  • Applying critical thinking skills to product development and design, troubleshooting technical issues in the lab.
  • Establishing testing plans and ensuring timely completion of technical deliverables.
  • Leading project development and overseeing tech transfer to manufacturing for clinical and commercial use.
  • Utilizing quantitative data analysis skills to inform decision-making processes and effectively communicate results.
  • Contributing to the intellectual property portfolio through innovative solutions.
  • Supporting a successful and efficient regulatory approval process, including 510(k) or PMA pathways, to ensure compliance with FDA requirements.
  • Maintaining accurate and timely records of development activities as per written procedures.
  • Collaborating across multiple functions, including Marketing, Regulatory Affairs, Quality, and Clinical Operation


Education & Experience

  • MS or PhD in life sciences, chemistry, material sciences, biomedical engineering or related field from an accredited college or university, or an equivalent combination of education and work experience. Relevant experience may be considered in lieu of advanced degree.
  • 1-3 years’ experience within Medical Device or Biotech industries.
  • Preferred experience in the development of drug-device combination products.
  • Preferred experience in one of the following areas: biological material such as collagen and decellularized ECM; polymer science; controlled release and drug delivery
  • Proven experience with Design Controls and the regulatory approval process, including FDA submissions such as 510(k) and PMA pathways.
  • Demonstrated success in a fast-paced, entrepreneurial environment.
  • Exceptional written, communication, and presentation skills

  • Research Engineer

    3 weeks ago

    Gaithersburg, Maryland, United States National Institute of Standards and Technology Full time

    **Research Opportunities**The National Institute of Standards and Technology (NIST) is a premier research organization that drives innovation and industrial competitiveness by advancing measurement science, standards, and technology. We are seeking a talented Research Engineer to join our team.Job DescriptionWe are looking for a skilled Research Engineer to...

  • Research and Development Engineer for Materials Analysis

    1 week ago

    Gaithersburg, Maryland, United States National Institute of Standards and Technology Full time

    About the Role: We're seeking an exceptional researcher to fill the position of Materials Scientist with XRD Expertise at the National Institute of Standards and Technology. As a member of our team, you will have the opportunity to apply your knowledge and skills in X-Ray Diffraction (XRD) to drive innovation and advancement in our...

  • Advanced Engineering Researcher

    2 weeks ago

    Gaithersburg, Maryland, United States National Institute of Standards and Technology Full time

    The National Institute of Standards and Technology is seeking an Advanced Engineering Researcher to join our Materials Measurement Science Division. As a key member of our team, you will play a pivotal role in advancing XRD science and enhancing measurement capabilities. The successful candidate will have expertise in advanced mathematical models of XRD...

  • Senior Research And Development Engineer

    3 days ago

    Gaithersburg, United States Elutia Full time

    Position Overview:The Senior R&D Engineer at Elutia is responsible for designing and developing biological-based medical devices, specializing in drug/device combination products according to industry standards. This role encompasses overseeing the entire development process, from initial concept through to commercialization. The R&D Engineer leads prototype...

  • Senior Research And Development Engineer

    3 days ago

    Gaithersburg, United States Elutia Full time

    Position Overview:The Senior R&D Engineer at Elutia is responsible for designing and developing biological-based medical devices, specializing in drug/device combination products according to industry standards. This role encompasses overseeing the entire development process, from initial concept through to commercialization. The R&D Engineer leads prototype...

  • Materials Research Engineer

    4 weeks ago

    Gaithersburg, United States National Institute of Standards and Technology Full time

    Summary Join NIST's Materials Measurement Science Division and play a pivotal role in advancing XRD science! We're seeking experts to enhance and innovate measurement capabilities, develop and certify SRMs, and be a part of impactful collaborations with the scientific community. This notice is issued under direct-hire authority to recruit new talent to...

  • Software Developer

    3 weeks ago

    Gaithersburg, Maryland, United States National Institute of Standards and Technology Full time

    **About Us**The National Institute of Standards and Technology (NIST) is a premier research organization that drives innovation and industrial competitiveness by advancing measurement science, standards, and technology. We are seeking a talented Software Developer to join our team.Job SummaryWe are looking for a skilled Software Developer to provide database...

  • Engineer II, Research Scientific

    1 month ago

    Gaithersburg, United States Meso Scale Discovery Full time

    Description POSITION SUMMARY An Engineering Scientist will work in a multi-disciplinary environment with other engineers and scientists to develop new products and advance existing products for life science, clinical, and biodefense applications. This position will assist in the development and manufacturing of consumables for biomarker measurements,...

  • Senior Engineer

    2 weeks ago

    Gaithersburg, Maryland, United States National Institute of Standards and Technology Full time

    **Job Overview**The National Institute of Standards and Technology (NIST) seeks a highly skilled Civil Engineer to join our Community Resilience Group. This position offers a unique opportunity to work on cutting-edge research projects focused on enhancing the resilience of buildings and infrastructure systems in the face of natural, man-made, and...

  • Research Engineer

    6 days ago

    Gaithersburg, United States X-wave Innovations, Inc. Full time

    X-wave Innovations, Inc. (XII) is a Research and Development (R&D) firm located in Gaithersburg, Maryland. We conduct state-of-the-art research and product development in the fast-evolving areas of Sensor Technologies, Ultrasound, Nondestructive Testing (NDT)/Structural Health Monitoring (SHM), Artificial Intelligence/Machine Learning (AI/ML), Electronic...

  • Research Engineer

    7 days ago

    Gaithersburg, United States X-wave Innovations, Inc. Full time

    X-wave Innovations, Inc. (XII) is a Research and Development (R&D) firm located in Gaithersburg, Maryland. We conduct state-of-the-art research and product development in the fast-evolving areas of Sensor Technologies, Ultrasound, Nondestructive Testing (NDT)/Structural Health Monitoring (SHM), Artificial Intelligence/Machine Learning (AI/ML), Electronic...

  • Senior Research Expert

    2 weeks ago

    Gaithersburg, Maryland, United States Nexcepta, Inc Full time

    Job OverviewNexcepta, Inc. is a technology leader providing cutting-edge R&D solutions, commercial products, and engineering services to federal and commercial customers. We seek a talented Research Scientist to join our interdisciplinary team of scientists and engineers in developing innovative technologies.Responsibilities- Participate in research...

  • Research Scientist Position

    2 weeks ago

    Gaithersburg, Maryland, United States Nexcepta, Inc Full time

    Job TitleWe are seeking Research Scientists to join our team at Nexcepta, Inc. in various research areas including communications, networks, cybersecurity, machine learning, data analytics, and computing.About the RoleThe selected candidates will work with an interdisciplinary team of scientists and engineers to develop cutting-edge...

  • Mechanical Engineer

    2 weeks ago

    Gaithersburg, United States National Institute of Standards and Technology Full time

    Summary Join the NIST Wildland Urban Interface team as a Mechanical Engineer! Lead groundbreaking fire experiments, develop innovative measurement systems, and shape safety standards. Collaborate, design, and implement cutting-edge solutions in fire science. Drive impactful research and make a difference. Apply today to ignite your career! This notice is...

  • Civil Engineer

    2 weeks ago

    Gaithersburg, United States National Institute of Standards and Technology Full time

    Summary The Department of Commerce ranked top 5 in the 2023 Best Places to Work in the Federal Government amongst large agencies for the 12th year in a row! The ranking showcases the Department's continued commitment to increasing our employee engagement, employee satisfaction, and positive perceptions towards diversity, equity, accessibility, and inclusion....

  • Research Scientist

    2 months ago

    Gaithersburg, United States Nexcepta, Inc Full time

    Job DescriptionJob DescriptionNexcepta, Inc. seeks Research Scientists in one or more research areas of communications, networks, cybersecurity, machine learning, data analytics, and computing. You will be working with an interdisciplinary team of scientists and engineers to develop cutting-edge technologies. Strong analytical and programming skills are...

  • Research Scientist

    4 hours ago

    Gaithersburg, United States Nexcepta, Inc Full time

    Job DescriptionJob DescriptionNexcepta, Inc. seeks Research Scientists in one or more research areas of communications, networks, cybersecurity, machine learning, data analytics, and computing. You will be working with an interdisciplinary team of scientists and engineers to develop cutting-edge technologies. Strong analytical and programming skills are...

  • X-wave Innovations, Inc. | Research Engineer

    7 days ago

    gaithersburg, United States X-wave Innovations, Inc. Full time

    X-wave Innovations, Inc. (XII) is a Research and Development (R&D) firm located in Gaithersburg, Maryland. We conduct state-of-the-art research and product development in the fast-evolving areas of Sensor Technologies, Ultrasound, Nondestructive Testing (NDT)/Structural Health Monitoring (SHM), Artificial Intelligence/Machine Learning (AI/ML), Electronic...

  • Mechanical Engineer

    1 week ago

    Gaithersburg, United States National Institute of Standards and Technology Full time

    Summary NIST works with industry and science to advance innovation and improve quality of life. We're looking for a Mechanical Engineer to join our team! This notice is issued under direct-hire authority to recruit new talent to occupations for which NIST has a severe shortage of candidates. Responsibilities Perform hardness measurements following...

  • Data Science and Engineering Lead

    2 weeks ago

    Gaithersburg, Maryland, United States Nexcepta, Inc Full time

    Lead Data Science and Engineering RoleNexcepta, Inc. seeks a skilled Research Scientist to lead our data science and engineering efforts in developing innovative technologies. As a key member of our interdisciplinary team, you will participate in research activities, write technical documents, develop software and prototypes, and collaborate with experts to...