Drug-Device Product Development Scientist

Scorpion Therapeutics; Boston (MA); On-site; USD 106,000 - 158,000; Full time

Job summary

Scorpion Therapeutics is seeking a Product Development Engineering Scientist focused on combination product development and drug delivery systems. You will author DHF records, perform risk analyses, and translate requirements into verifiable design outputs while supporting V&V activities.

You will collaborate with cross-functional teams in a highly matrixed environment, ensuring compliance with cGxP principles and ISO standards.

Qualifications

• Experience in medical device development and risk management deliverables.
• Knowledge of ISO 13485, ISO 14971, and 21 CFR 820.
• Experience authoring Design History Files and coordinating with cross-functional teams.

Responsibilities

• Author design history documentation for combination drug-device and/or biologic device products.
• Create risk analyses including DFMEA, UFMEA, PFMEA, and biocompatibility risk assessments.
• Translate User Requirements into Design Inputs and support Verification/Validation studies.

Skills

Medical device development

Technical writing

Cross-functional collaboration

Statistical methods

Education

Engineering degree

PhD (0–3 years)

MS (3+ years)

BS (6+ years)

Job description

Scorpion Therapeutics is seeking a Product Development Engineering Scientist focused on combination product development and drug delivery systems. You will author DHF records, perform risk analyses, and translate requirements into verifiable design outputs while supporting V&V activities.

You will collaborate with cross-functional teams in a highly matrixed environment, ensuring compliance with cGxP principles and ISO standards.