Description:
Hybrid - 3 days onsite
Hybrid role, candidate will be working primarily onsite at Client 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.
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