Planet Pharma ยท 2 hours ago
Sr Prin Systems Engineer
Moorpark, CA
Full-time
Onsite
Senior Level, Lead/Staff
5+ years expPlanet Pharma is seeking a Senior Principal Systems Engineer with extensive experience in Medical Device product development. The candidate will be responsible for executing various Systems Engineering tasks and managing software design history files, ensuring compliance with quality systems and standards.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Performs technical planning, system integration, verification and validation, evaluates alternatives including cost and risk, supportability and analyses for total systems
Analyses are performed at all levels of total system product to include: concept, design, fabrication, test, installation, operation, maintenance and disposal
Ensures the logical and systematic conversion of product requirements into total systems solutions that acknowledge technical, schedule, and cost constraints
Performs functional analysis, timeline analysis, detail trade studies, requirements allocation and interface definition studies to translate customer requirements into hardware and software specifications
Qualification
Required
Experience with Requirements Management
Experience with Medical Device Software (at least 5 years)
Medical Device experience is highly preferred
Experience in Medical Device product development
Experience with Requirements Management, Verification Trace Matrices, Protocol Creation, Test Execution, and Report Creation
Understanding of Medical Device quality systems
Experience in Design Verification and Validation
Experience with the Medical Device Software Lifecycle, specifically with the IEC 62304 Software Lifecycle Standard
BS in engineering, Computer Science
5 years minimum, 10 + Ideally
Preferred
Experience with JAMA software
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase