Reliability Engineer II

Reference: Posted: Location: Mounds View, MNCompany: Planet Pharma GroupContact: ApplicationsEmail: you please confirm your top 3 skills sets required? Problem Solving, Medical device experience, manufacutring supportCan you please confirm the 3 main responsibilities/day to day activities required for this role? Supporting programs/projects associated with pace makers and leads, supportings manufacturing sites and working cross functionally with teams to get deliverables completed.What products (if any) will this role support? (Pacemakers and leads)What is your target years of experience? 1-5 years experienceJob Summary
The Reliability Engineer II is responsible for ensuring the safety, reliability, and performance of products throughout the product lifecycle. This role partners cross-functionally with Design, Quality, Manufacturing, Regulatory, Supplier Quality, and Operations teams to identify and mitigate reliability risks, execute reliability assessments, and drive improvements that enhance patient outcomes and product performance. The Reliability Engineer II applies engineering principles, statistical methods, and reliability tools to support new product development, manufacturing processes, and post-market activities.Key Responsibilities* Lead and support reliability activities for new product development and sustaining engineering projects.* Develop and execute reliability strategies, plans, and test protocols aligned with product requirements and regulatory expectations.* Conduct reliability analyses including:
* Fault Tree Analysis (FTA)* Failure Modes and Effects Analysis (FMEA)* Design of Experiments (DOE)* Statistical data analysis* Support cross functional projects and programs.* Collaborate with cross-functional teams to investigate failures, conduct root cause analyses, and implement corrective and preventive actions.* Support Design Verification, Design Validation, and Design for Reliability (DfR) activities.* Develop accelerated life testing and environmental stress testing methodologies.* Evaluate supplier and manufacturing process reliability and identify areas for improvement.* Prepare technical reports, presentations, and recommendations for management and project teams.* Support regulatory submissions, audits, and compliance activities as required.* Contribute to continuous improvement initiatives that enhance product quality, reliability, and operational efficiency.* Mentor junior engineers and provide technical guidance on reliability methodologies and best practices.Required Qualifications* Bachelor’s degree in Engineering (Mechanical, Electrical, Biomedical, Industrial, Packaging, or related field).* Minimum of 2 years of engineering experience, including experience in reliability, quality, manufacturing, or product development.* Experience applying statistical analysis techniques and reliability engineering principles.* Knowledge of risk management and failure analysis methodologies.* Strong problem-solving and analytical skills.* Effective communication and collaboration skills.* Ability to manage multiple projects and priorities in a fast-paced environment.Preferred Qualifications* Experience in the medical device, pharmaceutical, aerospace, automotive, or highly regulated industry.* Knowledge of FDA, ISO 13485, IEC 60601, ISO 14971, or other applicable industry standards.* Experience with Minitab, JMP, ReliaSoft, MATLAB, or similar statistical/reliability software tools.* Experience leading cross-functional investigations and risk reduction initiatives.Key Competencies* Reliability Engineering* Statistical Analysis* Failure Analysis* Risk Management* Root Cause Investigation* Design for Reliability* Project Management* Technical Communication* Cross-Functional Collaboration* Continuous Improvement