Mounds View, MN, United States
Sep 18, 2021
We are seeking an Assoc Quality Engineer for a very important client.
The Reliability Engineer ? Design Assurance/ Reliability Engineering ensures safety and efficacy and performance of a product as intended over the product life cycle. The role involves supporting product development and continuous improvements in commercially released products. A Reliability/ Design Assurance Engineer will design and develop test methods, plan and oversee performance testing (design verification/ validation), apply statistical process control procedures, preform risk analysis and reliability studies for achieving required levels of product reliability.
Ideal candidate for this position must have an engineering degree with wide range of advanced analytical and statistical skills, strong technical aptitude and a good understanding of product development process and risk management activities. This position requires proficiency in combining these skills and experiences with the ability to communicate in a cross functional setting to achieve the best outcome with efficiency and innovation.
In collaboration with RA, QA, and R&D, support the revision of existing products.
- Execute and participate in FMEA/Risk Management activities.
- Serves as a technical resource for problem investigations to guide root cause analysis and corrective action development.
- Work in a cross-functional, collaborative, team-based environment
- Work under minimal supervision. Independently determine and develop approach to solutions.
- Contribute to the completion of specific programs and projects.
- Anticipate roadblocks; provide direction for navigating the quality system and supporting applications.
- Contribute to the completion of EUMDR project tasks and milestones in a collaborative team environment
- Provide timely updates to management on technical work progress and presentations regarding process/product improvements and/or root cause analysis
- Understand applicable regulations and standards that may apply to specific products and help ensure all standards are met in the process of new product development tasks
- Optimize current processes for efficient completion of EUMDR deliverables in a timely manner
- Completion of product risk management activities: 1) risk identification, 2) Risk Control, 3) risk assessment and risk/benefit evaluation, 4) and documentation of stated risk management processes
The ideal candidate will possess the following qualifications:
- Bachelor?s degree in Engineering or technical discipline
YEARS OF EXPERIENCE
- 2 years quality, reliability, or design assurance engineering experience
SPECIALIZED KNOWLEDGE REQUIRED
- Working knowledge of Statistical Analysis tools: DOE, Gage R&R, Confidence and Tolerance intervals, ANOVA, Capability, Hypothesis testing
- Experience executing risk management activities, including Risk Management planning, risk analysis techniques such as Failure Mode and Effects Analysis (FMEA), Fault Tree Analysis (FTA), and hazard analysis
- Knowledge of applicable ISO standards and FDA regulations
- GMP, QSR, ISO 13485, ISO 14971 experience
- Ability to effectively manage multiple competing priorities
- Strong written and verbal communication skills
- Good interpersonal and group leadership skills
- Basic PC skills (MS Word, Excel, PowerPoint, MS Project, etc.)
- Master's degree
- 5 years medical device or other regulated industry experience
- Experience with medical devices, in particular cardiac surgery devices
- Experience with reliability testing and analysis of medical devices
- Understanding of clinical/technical applications of cardiovascular products and human anatomy
- Certified Quality Engineer (CQE)
- Certified Reliability Engineer (CRE)
- Experience with ISO 5840, IEC 62366
- Effective negotiation, collaboration and influencing skills
Top skills manager is looking for
i. Risk Management experience
iii. Ability to self-direct
iv. EU MDR experience is a big plus.
How to Apply:
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