Senior R&D Engineer, Risk System Safety

An innovative, fast‑growing medical technology company is seeking a Senior (or Principal) R&D Engineer - System Safety to join its cross‑functional product development organization. In this role, you will lead product safety risk management activities and generate risk‑related deliverables throughout the full development lifecycle-from concept through commercialization.

This is a high‑impact position for an engineer who is passionate about safety, quality, and delivering breakthrough clinical technologies to patients.

• Develop and maintain risk management plans, hazard analyses, risk assessments, and risk management reports for new products.
• Facilitate identification of safety‑related characteristics for new features, new products, and new clinical indications.
• Lead cross‑functional hazard identification, risk analysis, and risk review activities across R&D, Product Assurance, Clinical/Medical, Manufacturing, and Regulatory teams.
• Guide teams on risk analysis, mitigation strategies, safety features, critical specifications, and safety‑critical product characteristics.
• Ensure risk control measures are incorporated into product requirements and design outputs.
• Define and validate verification methods to demonstrate the effectiveness of risk control measures.
• Maintain traceability between risks, design inputs/outputs, and V&V activities.
• Prepare risk management documentation for regulatory submissions.
• Partner with Clinical Affairs on risk‑related inputs for clinical study planning and execution.
• Support design transfer by identifying essential outputs and inspection methods based on risk.
• Contribute to post‑market surveillance by evaluating field data, determining safety actions, and updating risk files.
• Promote a collaborative, results‑driven culture with strong communication and teamwork.
• Maintain a safe, organized, and effective work environment.
  
  

• Bachelor's degree in Biomedical Engineering or related engineering/science discipline.
• 5 years of medical device product development experience.
• 2 years of experience in new product risk management.
• Strong working knowledge of ISO 14971 and risk management tools (FMEA, FTA, UEA, PHA, etc.).
• Excellent written and verbal communication skills; able to participate in engineering and clinical/medical discussions.
• Strong analytical and problem‑solving skills with high attention to detail.
• Familiarity with medical device standards such as IEC 60601‑x, IEC 62304, IEC 62366, ISO 13485 (preferred).
• Ability to travel up to 15% domestically.
  
  

We are open to hiring at the Senior or Principal level depending on experience. Compensation will be commensurate with qualifications and seniority.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.

To find out more about Real, please visit www.realstaffing.com