Lead Instructor: Medical Device Development for Scientists

Lead Instructor: Medical Device Development for Scientists

Location: Remote preparation with required in-person delivery in Washington, DC
Compensation: $150–$250 per hour, estimated project total of $8,000–$14,000, plus approved travel expenses
Engagement: Short-term, project-based, and contingent upon federal contract award

Position Overview

Strataegius LLC, an SBA-certified Service-Disabled Veteran-Owned Small Business, is seeking an exceptional medical-device development expert to serve as the lead instructor for a proposed two-day federal training course.

The selected instructor will deliver an in-person course in Washington, DC, for approximately 30 government scientists and professionals. The course will address the complete medical-device development lifecycle, from discovery and concept development through clinical studies, regulatory approval, commercialization, reimbursement, and post-market activities.

This is a contingent opportunity. Selection does not constitute a guarantee of employment or project award.

Required Qualifications

• Master’s degree or higher in biomedical engineering, regulatory science, medicine, life sciences, engineering, or a closely related field.
• At least five years of direct professional experience in medical-device development.
• Demonstrated experience advancing medical devices from concept through development, regulatory review, commercialization, or post-market support.
• Strong knowledge of:
• Medical-device discovery and development.
• Preclinical and nonclinical development.
• Investigational Device Exemptions and clinical investigations.
• FDA device classifications.
• 510(k), De Novo, and Premarket Approval pathways.
• Breakthrough Devices and Safer Technologies programs.
• Software as a Medical Device.
• Medical-device labeling.
• Patents and intellectual-property considerations.
• Coding, coverage, reimbursement, and CMS considerations.
• Post-market surveillance and medical-device recalls.
• Excellent instructional and presentation skills.
• Ability to deliver two days of in-person training in Washington, DC.
• Ability to satisfy applicable federal facility-access requirements.

Strongly Preferred

• Previous experience delivering professional training to scientists, engineers, executives, federal personnel, or other highly technical audiences.
• Direct experience with FDA submissions or bringing a medical device to market.
• Existing course materials, presentations, case studies, or exercises that can be adapted into a two-day course.
• Experience working with BARDA, FDA, HHS, NIH, DoD, VA, or another federal health organization.
• Knowledge spanning scientific, clinical, regulatory, intellectual-property, and commercial considerations.

Responsibilities

• Collaborate with Strataegius to develop or adapt a two-day course agenda.
• Provide practical, accurate, and current instruction covering the required subject areas.
• Incorporate relevant examples, case studies, exercises, and decision points.
• Prepare or adapt presentation slides, handouts, and supporting materials.
• Participate in limited proposal-development discussions before submission.
• Deliver the training in person in Washington, DC, if Strataegius receives the contract.

Final compensation will depend on qualifications, existing course materials, preparation requirements, travel, and the scope established by the final federal solicitation.

Application Requirements

Please submit:

• Your current résumé or curriculum vitae.
• A brief description of your direct medical-device development experience.
• A list of relevant courses or professional training you have delivered.
• A sample syllabus, course outline, or description of existing course materials, if available.
• Your expected hourly rate or project fee.
• Your availability for an anticipated two-day training engagement in Washington, DC, during the period of November 2026 to January 2027.

Strataegius will obtain the candidate’s written permission before including their name or résumé in any federal proposal.

Pay: $150.00 - $250.00 per hour

Expected hours: 10.0 – 20.0 per week

Work Location: In person