Engineer Senior, Drug Delivery Devices; JP
Listed on 2026-06-27
-
Engineering
Biomedical Engineer, Medical Device Industry, Quality Engineering, Product Engineer
Location: Newbury Park
Engineer Senior, Drug Delivery Devices
3 Key Consulting is recruiting an Engineer Senior, Drug Delivery Devices for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description:Lead 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
- Micro-infuser delivery pump systems.
The qualified candidate will lead 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 include:
- 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.
- Systems/Software Engineering background
- Strong problem solving, risk assessment, and risk management skills.
- Create and execute to project plans and schedules
- Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background need apply and will be considered!!!
- Third Party Supplier management
- Inventory analysis and management
- Analytical reporting and data collection
- BS in Engineering and previous experience in a medical device industry, supply chain and QA in a medical industry.
- 10 years current experience with engineering processes and procedures.
- Led projects from development through the 510k and PMA approval process.
- Strong background in engineering and commercialization of electro-mechanical 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 21
CFR
820 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.
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