Job Description
Job Description
Hybrid position - 3 days (T, W, & TH)
Local candidates only.
Job Title: Electrical/Quality Engineer
Duration: 12+ Months (Possible extension)
Location: Arden Hills, MN 55112
Hybrid Role (3 days a week)
Responsibilities:
- Must have an electrical background!
- Experience with Investigating and/or reviewing electronic circuits and components.
- This 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.
- 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.
- 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.
- 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.
Education/Experience:
- Bachelor’s degree or higher in Electrical or Biomedical Engineering
- BS with 1-3 years of relevant experience.
- Must have an electrical background!
- 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.
- Understanding and experience operating within quality system processes and procedures.
Preferred:
- 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.