Implantable Drug-Delivery Engineer II: From Design to Clinic

Continuity Biosciences, Inc.; North Carolina; On-site; USD 85,000 - 130,000; Full time

Job summary

Continuity Biosciences, Inc. in Cary, NC seeks a Product Development Engineer II to drive engineering for an implantable HIV prevention device from design freeze through first-in-human studies.

You will contribute to the design history file, run design verification, and work with contract manufacturers and testing labs to build and test the product. The role blends hands-on lab work with coordinating external partners and engineers at other sites, with potential growth to lead programs and

Qualifications

• Hands-on design control experience under 21 CFR 820.30 and ISO 13485.
• Proven ability to design, verify, and document medical devices or combination products.
• Strong technical writing and presentation skills to leadership.

Responsibilities

• Prepare design freeze package including BOM, drawings, specs.
• Write and execute design verification protocols for drug delivery devices.
• Coordinate with contract manufacturers and external labs for V&V.
• Develop test methods, fixtures, and prototypes; support regulatory submissions.

Skills

Design controls

Statistics for test design

Technical writing

Problem solving

Education

B.S./M.S. in mechanical/biomedical/chemical/materials engineering

PhD plus 1+ year medical device/pharma exp

Tools

SolidWorks

Job description

Continuity Biosciences, Inc. in Cary, NC seeks a Product Development Engineer II to drive engineering for an implantable HIV prevention device from design freeze through first-in-human studies.

You will contribute to the design history file, run design verification, and work with contract manufacturers and testing labs to build and test the product. The role blends hands-on lab work with coordinating external partners and engineers at other sites, with potential growth to lead programs and