Quality Engineer

Redbock - an NES Fircroft company; Minneapolis (MN); Hybrid; USD 70,000 - 95,000; Full time

Job summary

Redbock - an NES Fircroft company is seeking a Quality Engineer to investigate complaints and monitor product performance. You will analyze data, collaborate with cross functional teams, and help ensure patient safety through post-market surveillance.

The role involves responding to regulatory requests, applying statistical methods, and supporting process improvements across the QA function. Hybrid work arrangement in Arden Hills, MN with on-site days.

Qualifications

• Bachelor’s degree or higher in Electrical or Biomedical Engineering.
• 1–3 years of relevant experience in quality or engineering roles.
• Strong communication and data analysis skills.
• Understanding of quality system processes and procedures.
• Ability to manage projects to meet delivery dates.

Responsibilities

• Investigate product complaints and monitor client product performance.
• Review lab analyses, customer feedback, and data to code complaints.
• Conduct complaint investigations per local and global processes.
• Analyze post-market data for patterns and trends; support document releases.
• Respond to Competent Authority requests and communicate findings to teams.
• Contribute to process improvements and cross-functional project initiatives.
• Apply statistical methods to product performance and risk documentation.
• Engage in projects and lead cross-functional teams as needed.

Skills

Communication

Data analysis

Project management

Statistical methods

Quality systems

Technical writing

Cross-functional collaboration

Education

Bachelor’s degree or higher in Electrical or Biomedical Engineering

Engineering degree with 2-3 years of medical device experience

Job description

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

Length: 12 months

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.