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 multiyear programs.
Managing the overall program including creating and maintaining the project schedule identifying and mitigating program risks driving program task and coleading regular core team meetings.
Ensures that the product development process abides by all defined crossfunctional standards meets the intent and letter of SOPs and all compliance and regulatory needs of the applicable markets.
CoLeads the crossfunctional 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 crossfunctional integration problems leading the team to deliver per Product team commitments including (but not limited to) completing functional goals adjustments/iterations and crossfunctional teamwork.
Works with the Program Manager to ensure effective and efficient communication and for the duration of the crossfunctional 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 :
Bachelors / Masters 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 crossfunctional relationships including strong influential and communication skills
Interview Process: One phone and one virtual panel interview.
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