Product Development Engineer II — Implantable Devices

Continuity Biosciences, Inc.; Cary (NC); Vor Ort; USD 80.000 - 120.000; Vollzeit

Zusammenfassung

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

Role growth includes ownership of design history files, partner management, and program reporting. The ideal candidate has strong aseptic technique, design controls, and SolidWorks skills, with a track record of solving complex

Qualifikationen

• A Bachelor's or Master's degree in biomedical, mechanical, chemical, or materials engineering and 3+ years of industry experience in medical device or combination product development, or a PhD in one of these fields and at least 1 year of medical device or pharmaceutical industry experience.
• Hands-on aseptic technique and experience in a cleanroom or GMP environment.
• Experience with design controls (21 CFR 820.30, ISO 13485), verification testing with statistically justified sample sizes, and SOPs/batch records.
• Proficiency in SolidWorks or similar 3D CAD for fixtures, tooling, and component drawings.
• Record of solving technical problems independently and communicating results to leadership.

Aufgaben

• Build and package devices, including aseptic work for preclinical and clinical studies.
• Transfer assembly processes from lab to cleanroom and develop manufacturing steps for clinical release.
• Develop lab-scale manufacturing steps, including lyophilization of biologics.
• Plan and build preclinical device lots for multi-site animal studies with proper labeling and chain-of-custody.

Kenntnisse

Aseptic technique

Cleanroom operation

Design verification/validation

Communication to leadership

Project ownership

Ausbildung

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

PhD in related field (optional)

Tools

SolidWorks

Jobbeschreibung

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

Role growth includes ownership of design history files, partner management, and program reporting. The ideal candidate has strong aseptic technique, design controls, and SolidWorks skills, with a track record of solving complex