logo

View all jobs

Engineer Senior, Biotech

Thousand Oaks, CA · Biotech/Pharmaceutical
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 recruiting@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
 
 

Share This Job

Powered by