Job Details

Job Title: Engineer Senior, Biotech Combination Products - Hybrid (JP13322)
Location: Thousand Oaks, CA. 91320 (Hybrid)
Business Unit: Device Strategy Technology Assessment
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $44 - $48/hour W2 with benefits
Posting Date: 10/22/2024.
Notes: Only qualified candidates need apply. Hybrid - 3 days onsite working primarily onsite in Thousand Oaks, with ability to work remotely. Bachelors Degree in Engineering. 5+ years of experience within Pharma, Biotech, Med Device

3 Key Consulting is hiring! We are recruiting an Engineer Senior, Biotech Combination Products for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
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 include:

• Create and maintain project timelines.
• 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.

Top 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

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.
• 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.

Red Flags:
Less than 5 years of experience, jumpy job history.

Why is the Position Open?
Supplement to current team

Interview Process:
2 rounds of interviews

We invite qualified candidates to send your resume to ...@3keyconsulting.com . If you decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Regards,

3KC Talent Acquisition Team