Biomedical Engineer (Ultrasound / Mechanical)

We need to output HTML fragment with sections for headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections where there is real specific content. We must not repeat job title as heading. Must not include Job ID etc. Remove boilerplate. Must preserve all substantive info. We need to parse the posting: It includes company description, position summary, key responsibilities, relevant FDA regulations, desired technical expertise, qualifications, preferred additional experience, expected deliverables, position objective, citizenship requirement, EEO statement (remove), etc. We need to map to sections: - About the role: could be position summary and maybe position objective? The "About the role" heading is for a brief description. We can put position summary and maybe position objective there. - Responsibilities: key responsibilities list. - Requirements: maybe qualifications (education, experience) and citizenship requirement? Could be "Requirements" for mandatory qualifications. - Qualifications: maybe desired technical expertise? Actually qualifications often include education and experience. The posting has "Qualifications" section with bullet list. Also "Desired Technical Expertise" could be under Skills or Qualifications. We'll decide. - Skills: maybe desired technical expertise and preferred additional experience. - Benefits: not mentioned; no benefits info. So we should NOT include Benefits section. - Pay: not mentioned; omit. - Schedule: they gave "Schedule: Monday–Friday, excluding holidays". That's specific. So we need a Schedule section with that info. Also location: "Location: Silver Spring, MD". Could be part of About the role or maybe a short p. We need to avoid filler like "commensurate with experience". Not present. We must not include EEO boilerplate. We need to preserve all substantive info: company description, position summary, responsibilities, desired technical expertise, qualifications, preferred additional experience, expected deliverables, position objective, citizenship requirement, location, schedule, etc. We must not invent. We need to use

for section headings. Use

• for any list of duties/requirements/benefits. Use

  for prose. We need to decide what goes where. Let's outline:

  About the role

  Tunnell Government Services, Inc. is comprised of industry-leading scientists, medical and technical experts, and human capital and organizational development professionals. We approach all projects as a team and are committed to helping our clients transform and quickly achieve strategic goals. The FDA Center for Devices and Radiological Health (CDRH) seeks an experienced Biomedical Engineer Subject Matter Expert (SME) with specialized expertise in acoustics and/or ultrasonics to provide scientific, engineering, regulatory science, and technical support for the evaluation of medical devices. The SME will support regulatory review, regulatory science research, laboratory and computational analyses, and technical consultation involving diagnostic and therapeutic ultrasound technologies. Areas of particular interest include transcranial ultrasound, high-intensity focused/therapeutic ultrasound (HIFU/HITU), ultrasound metrology, acoustic output measurement, signal processing, tissue characterization, ultrasound neuromodulation, blood-brain barrier (BBB) opening, and histotripsy. The position will provide expert technical input on the safety, performance, design, development, testing, and validation of ultrasound-based medical devices and will support evaluation of emerging technologies and complex regulatory issues. The primary objective of this position is to provide specialized biomedical engineering, acoustics, ultrasonics, and regulatory science expertise to support CDRH's evaluation of diagnostic and therapeutic ultrasound technologies. The SME will apply advanced engineering and scientific knowledge to independently evaluate complex device designs, acoustic performance, testing, computational analyses, and safety data; conduct or interpret laboratory and computational research; and provide scientifically sound recommendations to support timely, consistent, and risk-based regulatory decision-making. The position will strengthen CDRH's technical capacity to evaluate emerging ultrasound technologies and address complex scientific and engineering issues associated with their safety and effectiveness.

  That covers position summary and objective.

  Responsibilities

  • Provide biomedical engineering expertise, with emphasis on acoustics and ultrasonics, in support of CDRH regulatory and scientific activities.
  • Provide consultation on diagnostic and therapeutic ultrasound devices, including transcranial and other advanced ultrasound technologies.
  • Support review of premarket submissions, including 510(k)s, PMAs, IDEs, De Novo requests, EUAs, combination products, and Pre-Submissions, as applicable.
  • Evaluate device design, acoustic performance, safety, testing, validation, and technical documentation.
  • Conduct or support regulatory science laboratory research and computational analyses involving ultrasound technologies.
  • Apply expertise in ultrasound physics, acoustic measurement and metrology, signal processing, tissue characterization, and computational modeling to address complex scientific and regulatory questions.
  • Evaluate emerging therapeutic ultrasound applications, including neuromodulation, BBB opening, histotripsy, HIFU/HITU, and transcranial ultrasound.
  • Review test reports, engineering analyses, validation data, computational models, and other technical documentation.
  • Support investigation of device failures, performance concerns, adverse technical findings, and other issues involving marketed devices.
  • Provide technical input regarding device safety, risk assessment, performance characterization, and benefit-risk considerations.
  • Prepare technical reviews, scientific assessments, reports, correspondence, presentations, and regulatory recommendations.
  • Participate in multidisciplinary meetings and communicate complex technical findings to scientific, clinical, engineering, and regulatory personnel.
  • Provide technical expertise regarding applicable FDA requirements, guidance documents, and consensus standards.

  Requirements

  Must be US Citizen or full Green Card holder.

  Maybe also include location? Could be in About the role or separate? The instruction: do not put Job ID/requisition numbers as headings — fold minor metadata into a short

  or drop it. Location is minor metadata; we could include in About the role paragraph or a separate short p under About the role. Let's add location in About the role paragraph: "Location: Silver Spring, MD". Already we have not included location. Let's add a sentence: "Location: Silver Spring, MD." Or incorporate. We'll adjust About the role paragraph to include location.

  Qualifications

  • Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Acoustics, Ultrasound Engineering, or a closely related scientific or engineering discipline.
  • At least 5 years of relevant professional experience in biomedical engineering, acoustics, ultrasonics, medical devices, or a closely related field.
  • Advanced degree (MS or PhD) in a relevant discipline is strongly preferred.
  • Demonstrated expertise in acoustics, ultrasonics, or medical ultrasound technologies.
  • Experience with medical device research and development, testing, validation, regulatory affairs, clinical evaluation, or sustaining engineering.
  • Experience with medical device regulatory review or direct support of FDA submissions is preferred.
  • Strong analytical, problem-solving, and technical writing skills.
  • Exceptional written and verbal communication skills.
  • Ability to explain complex scientific and engineering concepts to multidisciplinary audiences.
  • Ability to work independently and effectively as part of multidisciplinary technical teams.
  • Proficiency with Microsoft Office applications.
  But note: Some of these are also under "Desired Technical Expertise" and "Preferred Additional Experience". We need to avoid duplication. The posting has sections: Qualifications (the bullet list above), Desired Technical Expertise (list), Preferred Additional Experience (list), Expected Deliverables (list). We need to preserve all substantive info, but we should not duplicate content. We can combine similar items under appropriate sections. We have already used Qualifications for education/experience etc. We could put Desired Technical Expertise under Skills. Preferred Additional Experience could also be under Skills or maybe under Qualifications as "Preferred". But we need to avoid duplication: The Qualifications list includes some items that also appear in Desired Technical Expertise (e.g., demonstrated expertise, experience with medical device R&D, etc). Actually the Qualifications list we wrote is directly from the "Qualifications" section. The Desired Technical Expertise list is separate and includes more specific technical areas. We should keep both but ensure not to duplicate exact sentences. Let's extract the exact content: From posting: **Qualifications** - Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Acoustics, Ultrasound Engineering, or a closely related scientific or engineering discipline. - At least 5 years of relevant professional experience in biomedical engineering, acoustics, ultrasonics, medical devices, or a closely related field. - Advanced degree (MS or PhD) in a relevant discipline is strongly preferred. - Demonstrated expertise in acoustics, ultrasonics, or medical ultrasound technologies. - Experience with medical device research and development, testing, validation, regulatory affairs, clinical evaluation, or sustaining engineering. - Experience with medical device regulatory review or direct support of FDA submissions is preferred. - Strong analytical, problem-solving, and technical writing skills. - Exceptional written and verbal communication skills. - Ability to explain complex scientific and engineering concepts to multidisciplinary audiences. - Ability to work independently and effectively as part of multidisciplinary technical teams. - Proficiency with Microsoft Office applications. **Desired Technical Expertise** (Preference will be given to candidates with substantial expertise in one or more of the following): - Acoustics and ultrasound physics. - Transcranial ultrasound. - High-intensity focused or therapeutic ultrasound. - Ultrasound metrology and acoustic output measurement. - Ultrasound signal processing. - Ultrasonic materials and tissue characterization. - Ultrasound neuromodulation. - Ultrasound-mediated blood-brain barrier opening. - Histotripsy. - Medical ultrasound instrumentation and bioinstrumentation. - Ultrasound safety and performance evaluation. - Computational modeling of ultrasound fields or device performance. - Medical device testing and validation. - Regulatory science involving ultrasound technologies. **Preferred Additional Experience** (Preference may be given to candidates with): - Advanced training or research experience in acoustics, ultrasound physics, biomedical instrumentation, or therapeutic ultrasound. - Experience with acoustic measurement systems and ultrasound test methodologies. - Experience with computational modeling and simulation of ultrasound fields. - Experience evaluating ultrasound tissue interactions or biological effects. - Experience with medical device risk management. - Experience supporting FDA regulatory submissions or regulatory science activities. - Experience evaluating novel or emerging medical device technologies. **Expected Deliverables** (The SME may develop or contribute to): - Technical and regulatory reviews of medical device submissions. - Scientific and engineering assessments. - Ultrasound safety and performance evaluations. - Reviews of acoustic output and measurement data. - Laboratory and computational research analyses. - Technical assessments of device failures and performance concerns. - Written consultation memoranda, reports, and regulatory correspondence. - Technical recommendations and responses to regulatory review questions. - Meeting materials, presentations, and technical briefings. We need to map these to sections. We already used Qualifications for the qualifications list. For Skills, we could include Desired Technical Expertise (maybe as a list). For maybe "Expected Deliverables" could be under Responsibilities? But it's more like deliverables/output. Could be its own section but we only have headings list: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. No "Deliverables". So we need to fit deliverables somewhere, maybe under Responsibilities (as they are expected outputs). Or under Skills? Probably Responsibilities is appropriate: they are tasks/deliverables. We can add them to Responsibilities list. Similarly, Preferred Additional Experience could be under Skills as additional preferred skills. We must not create sections with filler. So we will have: - About the role (includes company description, position summary, objective, location) - Responsibilities (includes key responsibilities + expected deliverables) - Requirements (citizenship requirement) - Qualifications (education/experience etc) - Skills (desired technical expertise + preferred additional experience) - Schedule (Monday–Friday, excluding holidays) We should not include Benefits or Pay. Now ensure we don't repeat content. Let's craft. About the role paragraph: combine company description, position summary, objective, location. Let's write:

  Tunnell Government Services, Inc. is comprised