Senior Clinical Engineer

Scorpion Therapeutics; Santa Clara (CA); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k)/pension

Long-term incentive eligibility

Vacation 120 hrs/yr

Job summary

Scorpion Therapeutics in Santa Clara, CA is seeking a Senior Clinical Engineer for the OTTAVA Robotic Surgical System to drive clinical discovery, design, and validation with a cross-functional team.

You will work with physicians to characterize system performance, translate clinical needs into design inputs, develop validation plans, and support pre-clinical and regulatory activities, including training materials and initial product launches.

Qualifications

• Strong communication/interpersonal skills across cross-functional teams.
• Experience collaborating with physicians for clinical performance feedback.
• Experience designing and conducting pre-clinical engineering studies.
• Ability to identify clinical risks and conduct clinical harm analyses.
• Experience with Design Validation strategy, protocols, and testing.
• Ability to develop customer and engineering requirements.

Responsibilities

• Apply clinical, technical, and design control knowledge to discover, define, develop, and validate a new product with a cross-functional team.
• Partner with physicians and clinical users to characterize system performance and iterate.
• Translate unmet clinical needs into customer requirements and clinical design inputs.
• Benchmark system performance vs. current practice using clinical knowledge and data analysis.
• Develop bench models and metrics to ensure clinical performance needs are met.
• Develop clinical workflows, conduct clinical risk assessments, and propose mitigations for hazards.
• Collaborate with pre-clinical and regulatory teams to support pre-clinical studies.
• Create and execute design validation plans/protocols, conduct formal testing, and report results as required by FDA regulations.
• Support training materials, user manuals, labeling, and assessments.
• Support initial product launch and customer site bring-up.

Skills

Communication skills

Cross-functional collaboration

Pre-clinical studies

Risk analysis

Design validation

Requirements development

Education

BS in Biomedical/Mechanical Engineering

MS in Biomedical/Mechanical Engineering

PhD in Biomedical/Mechanical Engineering

Job description

Senior Clinical Engineer (OTTAVA Robotic Surgical System) — Santa Clara, CA.

Responsibilities

• Apply clinical, technical, and design control knowledge to discover, define, develop, and validate a new product with a cross-functional team.
• Partner with physicians and key clinical users to characterize system performance, gather feedback, and iterate.
• Identify unmet clinical needs and translate them into customer requirements and clinical design inputs.
• Benchmark system performance vs. current practice using clinical knowledge and data analysis in tissue models.
• Develop bench models and metrics to ensure clinical performance needs are met and maintained.
• Develop clinical workflows, conduct clinical risk assessments, and propose mitigations for hazards.
• Collaborate with pre-clinical and regulatory teams to support pre-clinical studies.
• Create and execute design validation plans/protocols, conduct formal testing, and report results as required by FDA regulations.
• Support training materials, user manuals, labeling, and assessments.
• Support initial product launch and customer site bring-up.

Required Qualifications/Skills

• BS in engineering (Biomedical/Mechanical) + 5 years medical device experience; or MS + 4 years; or PhD + 2 years.
• Experience collaborating with physicians for clinical performance feedback.
• Strong communication/interpersonal skills across cross-functional teams.
• Experience designing and conducting pre-clinical engineering studies.
• Ability to identify clinical risks and conduct clinical harm analyses.
• Experience with Design Validation strategy, protocols, and testing.
• Ability to develop customer and engineering requirements.

Preferred

• MS/PhD/MD.
• Knowledge of endoscopic/laparoscopic procedures and OR workflow; surgical robotics; FDA/IEC/ISO standards.
• Travel up to 15%.

Benefits (as stated)

• Medical, dental, vision, life insurance, disability; 401(k)/pension and long-term incentive eligibility.
• Time-off includes vacation (120 hrs/yr), sick time (40 hrs/yr; 56 hrs/yr in WA), holidays/floating holidays (13 days/yr), parental leave (480 hrs/yr).