Senior Device Engineer — Med Tech R&D & Validation

Scorpion Therapeutics; West Chester (Chester County); On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Health insurance

401(k) with employer match

Paid Time Off

Life and disability insurance

Tuition assistance

Flexible spending/HSA

Parental leave

Identity theft protection

Legal plan

Employee assistance program (EAP)

Job summary

Scorpion Therapeutics is seeking a Mechanical/Biomedical Engineer to lead device development under design controls, including prefilled syringes, autoinjectors, and wearables. You will run hands-on testing, fixture development, and FEM analysis while ensuring regulatory compliance.

Experience with 21 CFR 820/4, ISO 13485, and ISO 14971 is valued. Strong CAD (SolidWorks) and JMP/Minitab skills help drive robust product performance across teams.

Qualifications

• BS/MS in Mechanical or Biomedical Engineering (or related).
• 2–8+ years depending on level (Device Engineer II to Principal).
• Solid mechanics/design/materials/fluids and device performance.
• Hands-on testing and fixture development with components.
• Regulated development knowledge: design controls, QMS, risk mgmt; 21 CFR 820/4, ISO 13485, ISO 14971.
• Data analysis and cross-functional collaboration.
• Experience with parenteral delivery systems is a plus.
• CAD and statistics tools (SolidWorks, JMP/Minitab); FEM modeling.

Responsibilities

• Support or lead design-controls driven development of device systems.
• Develop/validate test methods and fixtures; test protocol execution.
• Perform hands-on testing/characterization of device + container-closure.
• Lead investigations and root-cause analyses for deviations, issues.
• Collaborate cross-functionally and prepare technical documentation.

Skills

Mechanical Eng

Biomedical Eng

Data analysis

Cross-functional collaboration

GxP knowledge

CAD/SolidWorks

FEM modeling

Education

BS/MS in Mechanical or Biomedical Eng

Tools

SolidWorks

JMP/Minitab

FEM

Job description

Scorpion Therapeutics is seeking a Mechanical/Biomedical Engineer to lead device development under design controls, including prefilled syringes, autoinjectors, and wearables. You will run hands-on testing, fixture development, and FEM analysis while ensuring regulatory compliance.

Experience with 21 CFR 820/4, ISO 13485, and ISO 14971 is valued. Strong CAD (SolidWorks) and JMP/Minitab skills help drive robust product performance across teams.