Product Development Engineer II, Implantable Drug Delivery

Continuity Biosciences; North Carolina; In loco; USD 85.000 - 130.000; Tempo pieno

Descrizione del lavoro

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

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Design controls

Statistics for test design

Technical writing

Problem solving

Formazione

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

PhD plus 1+ year medical device/pharma exp

Strumenti

SolidWorks

Descrizione del lavoro

Continuity Biosciences is a clinical stage biotechnology company in the Cary, North Carolina area. We develop precision drug delivery platforms that change how and where therapies reach patients, across oncology, Type 1 diabetes, HIV prevention, and medical aesthetics. Our lead oncology program has advanced into its first clinical trial in patients. We are a small, fast-moving team building a company where individual ownership has outsized impact.

The Role

We are hiring a Product Development Engineer II to drive engineering on a small implant placed under the skin that releases an HIV prevention drug at a steady rate for many months. From design freeze through the clinical builds for a first-in-human study, you will contribute to the device design history file, run design verification, and work with the contract manufacturers and testing laboratories that build and test the product. The role combines hands-on lab work with coordination of external partners and of engineers at our other sites. Over time, it has the potential to lead programs, including ownership of the design history file, partner management, and program reporting.

What You'll Do

Design and verification

• 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 our quality team, including hazard analysis and design and process FMEA under ISO 14971.

Manufacturing and testing

• Work with contract manufacturers through V&V builds, design transfer, and GMP clinical builds, including statements of work, technical reviews, and deviations.


• 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.

Development and documentation

• Write development and manufacturing content for regulatory submissions.


• Coordinate technical work with engineers at our other sites.


• Design fixtures and test methods, build prototypes, and run bench tests.

What You'll Bring

Must have

• A Bachelor's or Master's degree in mechanical, biomedical, chemical, or materials engineering and 3 or more 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 experience with the design control process under 21 CFR 820.30 and ISO 13485.


• Working knowledge of statistical methods for test design and data analysis, such as sample size justification.


• Proficiency in SolidWorks or a similar 3D CAD tool, including dimensioned production drawings.


• Clear technical writing, and comfort presenting technical results to leadership.


• A record of solving technical problems independently and carrying the solution through to implementation.

Nice to have

• Experience managing external vendors such as contract manufacturers, machine shops, or test laboratories.


• Experience with implantable devices, drug-device combination products, or long-acting drug delivery.


• Familiarity with manufacturing processes such as precision machining, laser welding, passivation, or injection molding.


• Experience with in vitro release testing, ISO 10993 biocompatibility, or sterilization processes.


• Experience leading teams or supervising junior engineers.


• Familiarity with GD&T, and exposure to IND, NDA, or BLA regulatory submissions.

Location & Work Arrangement

This is a full time, in person role at our Cary, North Carolina development center, with some travel, approximately 10% of the time. Laboratory and controlled manufacturing work requires gowning.

Compensation

A competitive base salary commensurate with experience, plus equity. As an early-stage company, we offer equity that gives you real ownership in what you help build.

Why Join

• Take an implant for HIV prevention from design freeze to its first clinical study.


• A path to leading programs as the company grows.


• A small, high trust team with real equity and a short path from idea to execution.