Reliability Engineer II
Redbock - an NES Fircroft companyMounds View, MN, US8 hours ago
Job type
- Full-time
Job descriptionComplaint trending Risk document updates Supporting Change orders 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. 1+ years of experience in Complaint handling or customer service / technical support experience Experience in handling complaint management Good Technical writing skills – The candidate will write complaint summaries, investigation, and analysis summaries on the complaints. Good communication skills 3+ years of experience in the medical device industry, with a strong background in Non -Conforming Materials Reports (NCMR), CAPA, or product quality management Proven experience leading NCMR and CAPA processes, ideally within a medical device or regulated industry Strong project management skills, with the ability to manage multiple priorities and deadlines Change control of Medical Devices Equipment Commissioning / Qualification Process Validation Computer System Validation (CSV) Manufacturing, Packaging and Laboratory Equipment Technical experience (Trouble shooting) or any similar experience or background Quality / Process Control / Assurance of Medical Devices Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations. Excellent problem-solving and analytical skills, with the ability to identify root causes and implement effective corrective actions. Outstanding communication and interpersonal skills, capable of effectively working with cross-functional teams and external stakeholders. Proficiency in Microsoft Office Suite and quality management systems (QMS). Strong technical writing capability. Experience in Process Validation.
Job Description
Reliability Engineer II (Through end of 2026 / / Mounds View, MN) :
Top Skills :
- Risk Management
- Complaint Trending
- Good Documentation Practices
Primary Responsibilities :
Target Years of Experience : 3-4 years of failure analysis and complaint trending experience
Duties :
Must Have
Nice To Have
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Reliability Engineer • Mounds View, MN, US
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