Senior Engineer

4 weeks ago

thousand oaks, United States Aditi Consulting Full time

Title: Senior Engineer (Medical Device)

Location: Thousand Oaks, CA

Duration: 12+ Months Contract

Description:

Hybrid - 3 days onsite

Hybrid role, candidate will be working primarily onsite at *** 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.

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

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