Implantable Drug-Delivery Engineer II — Equity & Impact

Continuity Biosciences, Inc.; Cary (NC); On-site; USD 100,000 - 140,000; Full time

Job summary

Continuity Biosciences, Inc. is hiring a Product Development Engineer II to drive engineering for a skin-implanted device delivering an HIV prevention drug over months.

You will contribute to the device design history file, run design verification, and collaborate with contract manufacturers and testing labs. The role blends hands-on lab work with coordinating engineers across sites and external partners, with potential to lead programs, own the design history file, manage partners, and report

Qualifications

• Bachelor's or Master's in mechanical, biomedical, chemical, or materials engineering with 3+ years in medical device or related field, or a PhD with 1+ year in medical device/pharma industry.
• Hands-on experience with design controls under 21 CFR 820.30 and ISO 13485.
• Working knowledge of statistical methods for test design and data analysis.
• Proficiency in SolidWorks or similar CAD tool with production drawings.
• Clear technical writing and ability to present results to leadership.
• Record of solving technical problems independently and carrying the solution through to implementation.

Responsibilities

• Prepare the design freeze package: design files, bill of materials, component drawings, and manufacturing specifications.
• Write and execute design verification protocols for drug release, mechanical integrity, and container closure.
• Maintain the design history file and risk management files with the quality team, including hazard analysis and design and process FMEA under ISO 14971.
• Coordinate third-party laboratory testing such as biocompatibility, chemical analysis, and sterilization.
• Build, document, and ship study devices for animal pharmacokinetic studies with full traceability.
• Write development and manufacturing content for regulatory submissions.
• Coordinate technical work with engineers at other sites.
• Design fixtures and test methods, build prototypes, and run bench tests.

Skills

SolidWorks

Design controls

Statistical methods

Technical writing

Problem solving

Education

B.S. or M.S. in engineering

PhD in engineering with 1+ year experience

Tools

SolidWorks

Job description

Continuity Biosciences, Inc. is hiring a Product Development Engineer II to drive engineering for a skin-implanted device delivering an HIV prevention drug over months.

You will contribute to the device design history file, run design verification, and collaborate with contract manufacturers and testing labs. The role blends hands-on lab work with coordinating engineers across sites and external partners, with potential to lead programs, own the design history file, manage partners, and report