Engineer Senior, Biotech

Job Title: Engineer Senior, Biotech
Location: Thousand Oaks, CA.
Employment Type: Contract
Duration: 12 months with possible extensions or conversion to FTE
Rate : $40 - $48/hour
Posting Date: 05/25/2024.
Responsibilities:

• Lead medium/small projects independently and work directly with Program Manager on large multi-year programs.
• Managing the overall program including creating and maintaining the project schedule, identifying and mitigating program risks, driving program task execution, and co-leading regular core team meetings.
• 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.
• Co-Leads the cross-functional Program Core Team to establish an integrated plan for resources and materials to deliver the new product program per the Product Delivery Team commitment.
• 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.
• Works with the functional engineering leadership team to grow project leadership skills within the Core Team
• 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 3 Must Have Skill Sets:

• Project management, design controls, drug delivery experience, risk based process
• Combination of product or medical device development experience.
• Nice to have: Mechanical testing experience.

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
• 4+ years' experience in project leadership in engineering product development, manufacturing or research environment, including previous leadership of a global and/or virtual team.
• 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

Interview Process:
One phone and one virtual panel interview.
We invite qualified candidates to send your resume to . 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 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