TARIS Biomedical is a unique therapeutically -focused urology company developing drug -device combination products f or the treatment of genitourinary diseases.
The Principle Engineer position resides within the Technical Operations group with the Product Development department. This position is responsible for development, manufacturing, packaging and distribution of drug-device combination products intended for clinical study and to support development of drug-device combination products in support of validation, product registration and commercial launch. This position requires the coordination of multiple internal and external cross-functional functions required to advance TARIS proprietary drug delivery products into clinical study and advance through late stage development to commercial release.
Primary responsibilities include but are not limited to the following:
- Manufacturing, packaging and distribution of TARIS proprietary drug delivery products and clinical supplies through the management of external vendors and Contract Manufacturing Organizations (CMO).
- Contribute as a Technical lead in selection of new vendors and transfer design as well as process technology to enable manufacturing of clinical trial supplies. The individual will support activities related to validation and commercialization.
- Interface with vendors and CMO on the development, fabrication and assembly processes required to meet TARIS’ program milestones.
- Lead the development and validation of drug/device fabrication and assembly manufacturing processes, incorporating new technology concepts as appropriate. Identify and implement process improvements to achieve manufacturing output, reduce cost of goods and maximize yield.
- Contribute to Human Factors Engineering efforts in order to develop safe and usable products that meet intended regulations. Collaborate with Product Research and Development to develop robust products that can be scaled up
- Plan and conduct lab scale product characterization and design verification studies to support design controls and regulatory submissions
- Technical Lead of the cross-functional Design Control team to ensure the Design Control processes and deliverables are implemented within the defined product development cycle and compliant with 21 CFR part 820 and ISO 13485.
- Develop test protocols/procedures and fixtures as needed to conduct testing,
- Develop manufacturing controls and procedure documentation
- Perform data analysis and generate technical reports in support of quality system requirements that meet CFR part 210/211 requirements
- Support authoring of CMC sections for regulatory submissions
- Ability to be a technical lead and /or manage internal and external (CMO) technical staff
- Expertise in device design (e.g. catheters), design control, manufacturing process development, process scale up, validation and commercial production preferred.
- Ability to develop strategy and execute experimental plans to address development objectives in alignment with corporate objectives with CMO’s
- Ability to write reports and clearly communicate technical information efficiently
- Knowledge of regulatory guidelines, submission content and process.
- Excellent writing, communication, presentation, and interpersonal skills.
- Ability to communicate across all levels of the organization.
- Experience with project management methodology and tools
- Strong knowledge of the quality system regulations and requirements (i.e. ISO, FDA-and cGMP as it relates to the development and manufacture of drug/ devices
- Excellent organizational skills, with close attention to details.
- Must be self-motivated and able to work autonomously
- Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast-paced team environment.
- Must be flexible and able to cope with constantly changing priorities.
- Demonstrated ability to stay abreast of trends and new information.
- Experience with machining, Instron and CAD (SolidWorks® preferred) is a plus
Qualifications and Experience:
- Degree in a relevant technical discipline (mechanical, chemical, biomedical, polymer, materials sciences engineering) or related field: Minimum requirements:
- BS with 16-18 years relevant industry experience or
- MS with 12-14 years relevant industry experience or
- PhD with 8-10 years relevant industry experience
- Extensive hands-on experience in design/prototyping of small components for implantable drug/device combination products or catheters, sheathes, and other urology or intravascular medical devices highly preferred
To apply, please send your CV to email@example.com