Quality Engineer

Medical Engineering Consultants (MEC) supports medical device and pharmaceutical companies by providing resources, knowledge, and expertise to augment and supplement their work. Our vision is to closely align clients’ needs with the best resources available, creating sustainable solutions that validate processes, ensure compliant quality systems, and close gaps between current and FDA-expected stages. MEC offers short or long-term support, from high-end leaders and consultants to skilled engineering staff and subject-matter experts. Our mission is to inspire positive cultural change and exceed client expectations.

Applicants must be authorized to work in the U.S. This position is not eligible for employer-sponsored work authorization now or in the future. Hybrid role located near Minneapolis, Minnesota.

About This Role

This quality engineer role will investigate product complaints and monitor product performance. The team uses product performance data and deep-dive analysis to assess whether products are performing as intended. Responsibilities include escalating post-market field performance signals, collaborating with cross-functional teams to mitigate risk, focusing on patient safety, and improving product performance.

Responsibilities

• Embody the client’s core values: Caring, Meaningful Innovation, High Performance, Global Collaboration, Diversity, and Winning Spirit.
• Review completed returned product lab analysis, customer feedback, and historical data to identify proper coding for product complaints.
• Perform complaint investigations in accordance with local and global processes.
• Analyze post-market surveillance data for patterns and trends, investigating as necessary.
• Query bounding data to support implementation of document releases.
• Respond to Competent Authority Requests.
• Communicate product performance via formal presentations to management committees and design teams, supporting published product performance reports and customer requests for performance information.
• Provide input for process improvement and help develop tactical approaches to implement team strategies.
• Perform data analysis for Product Performance and Risk Management documentation using statistical methods and software.
• Engage in projects, including outlining work plans with timelines, roles, and resources.
• Identify and lead cross-functional project teams comprised of functional experts and local managers.
• Remain open and flexible to changes in responsibilities, taking on new engineering tasks and product lines as the department evolves.
• Foster a diverse and inclusive workplace enabling full contribution toward organizational objectives.
• Investigate and review electronic circuits and components.
• Analyze 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

• Bachelor’s degree or higher in Electrical or Biomedical Engineering with 1-3 years of relevant experience.
• Must have an electrical background.
• Strong desire to be part of a team solving problems collectively.
• Understanding and command of highly technical engineering topics and applied statistics.
• Ability to independently manage project work and consistently meet delivery dates.
• Understanding and experience operating within quality system processes and procedures.
• Strong verbal and written communication 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 Hazard Analysis and Risk Assessment related to trend management.
• Strong technical writing skills.
• Experience with quality system escalations, CAPA investigations, and field assessments.
• Strong understanding of medical device regulatory requirements for post-market complaint tracking, trending, and analysis.
• Project experience or collaboration with Medical Safety, Design Assurance, Return Product Analysis, Supplier Development, and Manufacturing.