Sr Engineer

Location: Newbury Park
Posted on: October 30, 2024

Job Description:

Lead or support teams in the development of drug delivery devices. Scope includes a wide range of devices, such as; needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems. The qualified candidate will lead or support technical teams to ensure successful device development of these mechanical and electro-mechanical medical devices. The Senior Engineer will work closely with team members to develop detailed engineering specifications, device design & development, support verification, validation, and regulatory submissions of these devices. The role of the Senior Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development.

Responsibilities: - Work cross-functionally with individuals and project teams in Marketing, Operations, and Development - Create and assess product requirements to determine technical coverage and proper integration different subsystems. - Create and execute to project plans and schedules - Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects. - Provide deep technical assistance for junior engineers.

Skills:

- BS in Engineering and previous experience in a medical device industry with 2 - 10 years current experience with engineering processes and procedures.

- Led or participated in projects from development through the 510k and PMA approval process.

- Strong background in engineering and commercialization of electro-mechanical and disposable medical devices.

- Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.

- Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.

- Experience in drug/device combination product design and development

- Familiar with the following standards: o Quality System Regulation ? 21CFR820 o Risk Management ? ISO 14971 o EU Medical Device requirements ? Council Directive 93/42/EEC o Medical Electrical Equipment ? EN 60601 - Small scale device assembly experience.

- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.

- Strong problem solving, risk assessment, and risk management skills. - Must be capable of working on multiple projects in a deadline driven environment. Plastic part design experience is a plus. We are an equal employment opportunity employer and will consider all qualified candidates without regard to disability or protected veteran status.

Keywords: , Mission Viejo , Sr Engineer, Engineering , Newbury Park, California