Planet Pharma ยท 3 hours ago
Software Reliability Engineer II
Mounds View, MN
Full-time
Onsite
Entry, Mid Level
2+ years expPlanet Pharma is a company that focuses on cloud software products and is seeking a Software Reliability Engineer II. The role involves conducting reliability studies, recommending design methods for product reliability, and performing risk analysis on new designs and processes.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs
Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability
Completes risk analysis studies of new design and processes
Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes
Ensures that corrective measures meet acceptable reliability standards
Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives
May develop mathematical models to identify units, batches or processes posing excessive failure risks
As necessary, proposes changes in design or formulation to improve system and/or process reliability
May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data
Qualification
Required
critical thinking
knowledge of quality management systems
knowledge of risk management processes
software reliability testing
software reliability FMEA (failure mode effects analysis)
GSPR (general safety performance requirements)
0 - 5 years of experience
University Degree
minimum of 2 years of relevant experience
Preferred
Critical thinking and problem-solving skills, including application of structured problem-solving methods and tools
Written and oral communication skills, including the ability to summarize complex technical concepts and problems clearly and concisely
collaboration and influence skills
Advanced degree in engineering, science, or equivalent field
Exposure to or experience working in or with Design, Quality, Regulatory, Clinical and/or Manufacturing
Certified Reliability Engineer (CRE), Certified Software Quality Engineers (CSQE) or equivalent certification
Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g., PHA, HA, FTA, DFMEA)
Experience with Software Reliability Engineering models including growth models
Ability to independently lead investigations to identify system/product failures, hazards, hazardous situations, and harms
Experience in the design, maintenance, or continuation engineering of released software or software systems, including mobile applications
Experience with automated and/or manual software tests
Experience with Agile or behavior-based development
Experience in medical devices or other regulated industry
Experience with 21 CFR Part 820 (Quality System Regulation), ISO 13485, etc
Experience working with IEC 62304
Knowledge of Design for Six Sigma (DFSS), Design for Lean Sigma (DFLS), Design for Reliability and Manufacturability (DRM), or other robust design practices
understanding of and experience in the application of statistics, including experience with Minitab
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