Device Engineer at ACL Digital

Title: Senior Engineer

Location: Thousand Oaks, CA

Duration:12+Months

Description:

Hybrid - 3 days onsite

Hybrid role, candidate will be working primarily onsite at Amgen Thousand Oaks, with ability to work remotely

• Bachelors Degree in Engineering

• 5+ years of experience within Pharma, Biotech, Med Device

Responsible for planning, executing and reporting test activities for combination product teams. Coordinates with technical leads and cross functional teams to ensure deliverables needed for device design feasibility, characterization and verification stages are completed on time with high quality standards.

Scope includes a wide range of devices, such as; needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors. The qualified candidate will coordinate with technical teams to ensure successful device development of these medical devices. The Senior Engineer will work closely with team members to develop detailed engineering deliverable timelines, directing and monitoring work efforts on a daily basis, identifying resource needs; and escalating functional, quality, timeline issues appropriately. The qualified candidate will support verification, validation, and regulatory submissions of these devices. Work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development.

Responsibilities:

Ensures that the product development process abides by all defined cross-functional standards, meets the intent and letter of SOPs and all compliance and regulatory needs of the applicable markets.

Identifies early and solves complex and ambiguous cross-functional integration problems leading the team to deliver per Product team commitments including (but not limited to) completing functional goals, execution adjustments/iterations, and cross-functional teamwork.

Works with the Program Manager to ensure effective and efficient communication and execution for the duration of the cross-functional program team.

Works with the system, subsystem/platform, supply chain, service, QA, RA, Research project leaders to deliver quality products on time, within budget and with the necessary features/functionality.

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.

Qualifications/Requirements :

Bachelor's / Master's Degree in Electrical/Mechanical /Biomedical Engineering Computer Engineering or equivalent experience

Medical device and/or combination product development experience; design controls experience

5+ years of more progressive responsibility and experience as an engineer or scientist

Demonstrated ability to build lasting cross-functional relationships, including strong influential and communication skills

Demonstrated understanding/experience with the New Product Introduction (NPI) cycle and cross-functional interdependencies

Familiarity with test equipment such as Instron.

Basic Qualifications

Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience

Max Rate Not to Exceed (If this differs from the job posting template):

Top 3 Must Have Skill Sets:

Testing experience

Product Development

Experience with design controls and medical device regulations

Drug delivery/combination product experience

risk based process

presentation skills

Day to Day Responsibilities:

Author device documentation to support development, planning, verification, validation, and transfer

Author test protocols and execute mechanical testing of drug delivery devices

Presentation and communication skills (within program teams)

Execute and deliver within regulated development processes

Proactively maintains close communication with technical leads

Create and maintain project timelines