Product Development Engineer II — Medical Devices (Cleanroom)

Continuity Biosciences, Inc.; North Carolina; On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Equity

Job summary

Continuity Biosciences, Inc. is seeking a Product Development Engineer II to advance intratumoral drug delivery implants. You will work hands-on in our Cary lab and ISO 7 cleanroom, transforming lab processes into documented, repeatable manufacturing for clinical release.

The role offers growth toward leading programs, ownership of the design history file, and collaboration with cross-functional teams in a fast-moving startup environment.

Qualifications

• Requires a Bachelor's or Master's in biomedical, mechanical, chemical, or materials engineering with 3+ years in medical device or combo product development, or a PhD with 1+ year in the field.
• Hands-on aseptic technique and cleanroom or GMP environment experience.
• Experience with design controls (21 CFR 820.30, ISO 13485) and verifying with statistically justified sampling.
• Proficiency in SolidWorks or similar 3D CAD tool for fixtures, tooling, and drawings.
• Ability to independently solve technical problems and drive solutions to implementation.

Responsibilities

• Build and package devices in aseptic conditions for preclinical and clinical studies.
• Transfer device assembly processes from labs into a manufacturable cleanroom process for clinical release.
• Develop lab-scale manufacturing steps including lyophilization of biologic products.
• Plan and prepare preclinical device lots for multi-site animal studies with proper labeling and chain-of-custody.

Skills

Aseptic technique

Cleanroom experience

Design controls

Statistical sampling

Documentation

SOPs

Education

Bachelor's or Master's in biomedical, mechanical, chemical, or materials engineering

PhD in one of these fields (with at least 1 year of industry experience)

Tools

SolidWorks

Job description

Continuity Biosciences, Inc. is seeking a Product Development Engineer II to advance intratumoral drug delivery implants. You will work hands-on in our Cary lab and ISO 7 cleanroom, transforming lab processes into documented, repeatable manufacturing for clinical release.

The role offers growth toward leading programs, ownership of the design history file, and collaboration with cross-functional teams in a fast-moving startup environment.