What are the responsibilities and job description for the Sr. Reliability Engineer position at Redbock - an NES Fircroft company?
Sr. Reliability Engineer (12-month contract // Mounds View, MN):
On Site Requirement: After training is complete, contingent worker will be working onsite at Mounds View 3 days a week (Tuesday, Wednesday, and Thursday) and WFH 2 days a week (Monday and Friday). During training, contingent worker will be working onsite at Mounds View (5 days/week).
W2 ONLY - cannot work C2C/sponsor visa*****************************
Top Skills:
- Understanding of QMS (ISO 13485, FDA 21 CFR Pat 820) and EU MDR
- Experience with post market risk management
- Candidate will support authoring and documenting Periodic Safety Update Reports (PSURs) in a timely manner
- Documentation / MAP Agile experience
Target Experience:
- 3 years of post-market / pre-market quality experience
- Previous experience with Medical Devices / EU MDR / Risk Management is a plus
Description:
In this role, you will investigate issues and analyze the risks for products in the field. This includes trends in complaint data, labeling, packaging, and use related issues. You will prepare post market surveillance deliverables by coordinating with technical and clinical experts across the operating unit.
Duties:
- Develop Post Market Surveillance Plans and Periodic Safety Update Plan and Reports.
- Conduct descriptive analysis on data to detect data quality problems. Perform advanced statistical analysis on experimental or business data to confirm and quantify trends or patterns identified by the business.
- Analyze performance data trends to identify opportunities for advanced analytics, quality improvements, and/or cost savings.
- Compile and analyze performance reports and process control statistics; investigate and analyze relevant variables potentially affecting product and processes.
- Deliver projects assigned and work with other stakeholders to achieve desired results.
- Work independently under limited supervision to determine and develop approach to solutions.
- Communicate with senior internal and external customers.
- Exchange information of facts, statuses, ideas, and issues to achieve objective, and influence decision-making.
Required Knowledge and Experience:
- Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience. Position works a hybrid model and will be onsite in Mounds View, MN – 3 days per week.
Must Have Experience:
- Probability and Statistics
- Investigation and root cause analysis skills
- Accurate data trend analysis
- Analysis of product reliability testing and field failures
- Complaint Trending and Investigation Experience
- Good Documentation Practice
Preferred Skills:
- Experience with Spotfire, Excel, SAP, and PowerBI.
- Analysis and development of corrective action and preventive action plans
- Post Market Quality and Clinical
- Corrective & Preventive Actions (CAPA), Issue Impact Assessments (IIA) and Non-Conformance Integration
- Exposure to authoring PSURs is strongly preferred
- Post Market Risk Management experience
- Design Failure Mode and Effect Analysis (DFMEA)
- UFMEA
- Charting/visualization tools (e.g., Tableau, Spotfire)
- Excel, SAP and PowerBI, Visio
