Reliability Engineer II - Exempt
Lancesoft
Mounds View, MN
Join our dynamic team in Mounds View, MN, where you will have the opportunity to work on cutting-edge Cardiac Rhythm Management (CRM) products, including pacemakers, leads, and defibrillators. We offer a collaborative work environment with a focus on innovation and continuous improvement.
Responsibilities
- Develop, coordinate, and conduct technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.
- Recommend design or test methods and statistical process control procedures to achieve required levels of product reliability.
- Complete risk analysis studies of new designs and processes.
- Compile and analyze performance reports and process control statistics;investigate and analyze relevant variables potentially affecting products and processes.
- Ensure that corrective measures meet acceptable reliability standards.
- Support MDR shelf life deliverables for accelerated aging and real-time aging.
- Support client mark renewal deliverables with notified bodies and continue to support projects requiring reliability demand.
- Analyze preliminary plans and develop reliability engineering programs to achieve company, customer, and governmental agency reliability objectives.
- Propose changes in design or formulation to improve system and/or process reliability as necessary.
- May determine units and/or batches requiring environmental testing and specify the minimum number of samples to obtain statistically valid data.
- 1-4 years of experience in the Medical Device industry.
- Familiar with FDA 21 CFR Part 820, EU 217/745 (EU MDR).
- Knowledge of ISO 13485, ISO 14971, IEC 60601 standards.
- Computer literacy in Microsoft Office Applications (Word, Excel, Access, and PowerPoint) and Windows OS.
- Strong written and verbal communication skills and ability to work cooperatively as part of a cross-functional team.
- Experience in Biomedical Engineering, Electrical Engineering, and Risk Management is preferred.
This position requires working on-site in Mounds View, MN, four days a week, with a start date expected between mid-April and early May. We are looking for candidates who can start interviewing as soon as possible and are ready to begin their role promptly.
About the Company
Lancesoft
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.