Sr Engineer

Unclassified - Thousand Oaks, CA

Full-time - Mid Level

Thousand Oaks, CA

About the position

The Senior Engineer will lead or support teams in the development of a variety of drug delivery devices, including needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems. This role involves working closely with cross-functional teams to ensure successful device development, focusing on engineering specifications, device design, verification, validation, and regulatory submissions.

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 of different subsystems.
• Create and execute project plans and schedules.
• Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plans, verification and validation plans, and other related product development documents for assigned projects.
• Provide deep technical assistance for junior engineers.

Requirements

• BS in Engineering and previous experience in the medical device industry with 2 - 10 years of 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: Quality System Regulation ? 21CFR820, Risk Management ? ISO 14971, EU Medical Device requirements ? Council Directive 93/42/EEC, 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.

Nice-to-haves

• Plastic part design experience.

Benefits

• Equal employment opportunity employer, considering all qualified candidates without regard to disability or protected veteran status.