Quality Engineer

Redbock - an NES Fircroft company; Arden Hills (MN); Hybrid; USD 30,000 - 51,000; Full time

Job summary

Redbock - an NES Fircroft company in Arden Hills, MN is seeking a Quality Engineer to investigate product complaints and monitor client product performance. The role involves analyzing post-market data, communicating findings to management, and supporting risk mitigation efforts to improve product safety and performance.

The team is collaborative and environment focuses on quality systems, data analysis and cross-functional work.

Qualifications

• Bachelor's degree in Electrical or Biomedical Engineering or higher.
• Understanding of statistics and data analysis in a quality environment.
• Ability to manage projects and deliver on schedules.
• Familiarity with quality system processes and CAPA.

Responsibilities

• Investigate product complaints and monitor performance data.
• Perform post-market surveillance data analysis and trend reviews.
• Coordinate with cross-functional teams to mitigate risk and protect patient safety.
• Respond to regulatory and authority requests with accurate documentation.
• Support process improvements and contribute to product performance reports.
• Assist with data queries and documentation for product releases.

Skills

Statistical analysis

Data analysis

Quality systems

Project management

Communication skills

Education

Bachelor's degree in Electrical or Biomedical Engineering

Job description

Location: Hybrid, 3 days/week (Tues, Wed, Thurs) on-site in Arden Hills, MN. Local candidates only

Pay rate: Max PAY for level I engineer is $37/hr. Candidates must be W2 or C2C, no 3rd party

Length: 12 months

Additional Notes: This role does not touch product. Will be working with a very collaborative team of 12.

Summary

This quality engineer role will investigate product complaints and monitor client product performance. The team uses product performance data and deep dive analysis to understand if products are performing as intended. Escalating post-market field performance signals to better understand what the data is telling us, collaborating with cross functional teams to mitigate risk focusing on patient safety and improving product performance.

Duties/Responsibilities

• Embodying client's Core Values of Caring, Meaningful Innovation, High Performance, Global Collaboration, Diversity, Winning Spirit.
• Reviewing completed returned product lab analysis, customer feedback and historical data to identify proper coding for product complaints.
• Performing complaint investigations in accordance with local and global processes.
• Analyzing post market surveillance data for patterns and trends and investigating when necessary. May be responsible for querying & bounding data to support implementation of document releases.
• Responding to Competent Authority Requests.
• Communicating product performance by formal presentations to management committees and design teams, supporting published product performance reports and customer requests for performance information either directly or through the sales organization.
• Providing input for process improvement and helping develop tactical approaches to implement team strategies.
• Perform data analysis for Product Performance and Risk Management documentation by applying statistical methods and software.
• May be asked to engage in projects/project plans outlining work plans including timelines, roles and resources; Identifies and leads cross-functional project teams comprised of functional experts and local managers
• Open and flexible to change in responsibilities, taking on new engineering tasks and new product lines as the department grows and evolves.
• Fostering a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Investigates and reviews electronic circuits and components.
• Analyzes returned products to address complaints.
• Assist Lab Technicians during complaint investigations to ensure accurate and compliant product analysis and documentation.
• Review completed product analysis to ensure field allegations are adequately addressed.

Qualifications/Requirements

Minimum Qualifications:

• Bachelor's degree or higher in Electrical or Biomedical Engineering
• BS with 1-3 years of relevant experience.
• A strong desire to be a part of a team that looks to make a difference each day to collectively solve problems.
• Understanding and a command of highly technical engineering topics and applied statistics.
• Ability to independently manage project work to define and consistently meet delivery dates.
• Understanding and experience operating within quality system processes and procedures.
• Strengths in communication (verbal and written) and data analysis skills.

Preferred Qualifications

• Engineering Degree with 2-3 years of relevant medical device experience.
• Experience in physical device analysis.
• Strong technical understanding of medical device therapy products.
• Significant participation in the Hazard Analysis and Risk Assessment as related to trend management.
• Strong Technical Writing skills.
• Experience with the quality system escalations, CAPA investigations and field assessments.
• Strong understanding of the medical device regulatory requirements of post-market complaint tracking, trending and analysis.
• Project experience and/or collaboration with Medical Safety, Design Assurance, Return Product Analysis, Supplier Development and Manufacturing.