Sr Device Engineer

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

How You’ll Spend Your Day:

• Support or lead combination product development under design controls (user needs, inputs/outputs, traceability, risk management, verification planning, test protocols/reports, design history file).
• Develop/execute/document engineering studies and statistically sound test strategies for device performance, robustness, manufacturing variation, and lifecycle changes.
• Perform hands‑on testing/characterization of device + container-closure systems (injection force, break‑loose/glide/extrusion force, injection time, dose accuracy, closure integrity, component fit/function).
• Develop/qualify/validate physical test methods and fixtures; use lab equipment/tools (Instron/Zwick, fixtures, microscopy, CT, silicone coating analysis, CAD, statistical tools).
• Lead/support investigations and root cause analyses for deviations, complaints, manufacturing/supplier issues.
• Apply systems/mechanical engineering (solid mechanics, materials, fluid dynamics, tolerance analysis, DFM, modeling/FEM as appropriate).
• Collaborate cross‑functionally and prepare technical documentation (protocols, reports, lab records, investigation summaries, verification evidence, change assessments, regulatory submission content).

Your Skills and Experience:

• BS/MS in Mechanical or Biomedical Engineering (or related).
• Approx. 2–4 yrs (Device Engineer II), 4–6 yrs (Senior), 6–8+ yrs (Principal); advanced degrees may offset.
• Foundation in mechanical/solid mechanics/design/materials/fluid dynamics and device performance evaluation.
• Hands‑on physical testing/fixture development and component/device characterization.
• Regulated development knowledge (design controls, quality systems, risk management, GxP/Good Documentation Practices; e.g., 21 CFR 820/4, ISO 13485, ISO 14971).
• Data analysis, clear communication, cross‑functional collaboration.
• Experience with prefilled syringes/autoinjectors/on‑body/wearable/needle safety or other parenteral delivery systems.
• CAD/statistical tools (e.g., SolidWorks, JMP/Minitab), modeling/FEM/first‑principles.
• Familiarity with biologics/container‑closure interactions and filings (IND/BLA/MAA), human factors/usability, verification and test method validation.

Benefits (explicitly listed):

• Comprehensive health insurance
• 401(k) with employer match
• Paid Time Off
• company-paid life/disability
• additional listed programs (e.g., EAP, tuition assistance, flexible spending/HSA, parental leave, identity theft protection, legal plan).