Principal Systems Engineer (Drug delivery devices OR Aerospace)

Company: Infotree Service
Location: Thousand Oaks
Posted on: May 3, 2021

Job Description:

Company DescriptionBio-TechJob DescriptionCandidate will be working remote until the site reopens then required to be on site* Masters/Bachelors 5+years OR Doctorate 3+ years of System Engineering experience in Drug Delivery or Aerospace*Prefers the candidate to have experience in electromechanical drug delivery devices*Prefers the candidate to have experience in requirements management tool such as DOORSThe Principal Systems Engineer guides the identification, development, commercialization and improvement of drug delivery technologies to provide efficient patient experience in administration of client therapeutic products. The PSE will report to our Director of Systems Engineering & Risk Management.As a leader in the organization, the PSE will ensure the success of multi-functional drug delivery and combination product development efforts through their lifecycle from feasibility through commercial manufacture. The PSE will work in collaboration with commercial and research colleagues in identification of user needs from market insights. The PSE will lead creation and management of system requirements, development of system architecture, and integration of subsystems. This will require ensuring robust system architecture across the interactions, dependencies, and interfaces of subsystems.The PSE will lead integration of the system through clinical and market entry. The successful candidate will have demonstrated strength and success in managing interactions with key partners and colleagues from across process development, operations, research and development, and global commercial organizations to ensure accurate capture of the voice of customer and business into user needs.RoleResponsibilities:Lead development of robust drug delivery systems and coordinated development efforts utilizing best Systems Engineering principles in combination product development cycles.Lead formal and ad-hoc technical and design reviews for the coordinated systemOrchestrate system definition in conformance to global regulatory principles and best engineering methods including User Needs and System Design InputsResponsible for DHF development and transparency of structure across platform, combination product, and vendor structures to ensure quality and visibilityOwns integration of requirements, risks, and implemented mitigations through downstream design outputs.Drives system verification and validation strategies across platform and brand-specific presentations.Owns system performance & reliability targets and subsystem allocationsProvides authorship and expert technical leadership for regulatory filingsResponsible for mentoring, supervision, and advised professional development of more junior engineersQualificationsMasters/Bachelors 5+years OR Doctorate 3+ years of System Engineering experience in Drug Delivery or AerospaceAdditional InformationTop 3 Must Have Skill Sets:1. Solid knowledge of systems engineering principles, preferably in biotechnology but also in other industries2. Good experience working in cross-functional teams3. Successful experience managing multiple projects in a deadline driven environmentSummaryType: ContractFunction: EngineeringSDL2017

Keywords: Infotree Service, Thousand Oaks , Principal Systems Engineer (Drug delivery devices OR Aerospace), Other , Thousand Oaks, California