Product Development Engineering 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

General Summary:

The Product Development Engineering Scientist focuses on combination product development, with a particular focus on drug delivery systems.

Key Duties And Responsibilities:

• Collaborate with cross-functional teams to author design history documentation of combination drug-device and/or biologic device products.


• Author Risk Analyses, including DFMEA, UFMEA, PFMEA, and biocompatibility risk assessments.


• Translate User Requirements into Design Requirements; correlate Design Inputs with Design Outputs; support Design Verification and Validation Studies (internally and externally).


• Manage Change Control, Deviations and Non-conformances with cross-functional teams for impact assessment and investigations; ensure timely completion and updates to the Design History File.


• Perform Design History File maintenance, including review/revision of Design and Quality System Documentation.


• Ensure completeness and alignment with User Requirements, Functional Requirements, and Design Inputs.

Knowledge And Skills:

• Proven experience with Medical Device Development, including ownership/authorship of design and development file records and risk management deliverables.


• Experience with medical device packaging development and mechanical performance testing (preferred).


• Working knowledge of test methods for selecting, verifying, and validating components/sub-systems/assemblies.


• Ability to present to cross-functional teams for input and design/risk file updates.


• Experience executing workstreams in highly matrixed environments.


• Strong understanding of cGxP principles and practices; ISO 13485, ISO 14971, and 21C.F.R.820.


• Strong statistical principles; strong technical writing and presentation skills.

Education And Experience:

• Degree in Engineering preferred (other related disciplines considered).


• PhD (0–3 years), M.S. (3+ years), or B.S. (6+ years).

Pay Range:

$105,600 - $158,400