Quality Engineer

Medical Engineering Consultants (MEC); Minnesota; Remote; USD 90,000 - 130,000; Full time

Job summary

Medical Engineering Consultants (MEC) is seeking a Quality Engineer for a remote position in the United States, focusing on remediating test methods, work instructions, and training technicians involved in investigations of return and non-return products.

You will review investigations for accuracy and collaborate across Post Market, R&D, Design Assurance, Operations, and Manufacturing to ensure root cause is well understood.

Qualifications

• Bachelor's degree in electrical engineering or related field with 4+ years of relevant experience.
• Structured problem-solving and failure analysis capabilities for electronics systems/components.
• Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook.
• Excellent written and verbal communication; ability to collaborate across teams.
• Strong data analytics capabilities.

Responsibilities

• Provide leadership on cross-functional engineering initiatives.
• Understand failure modes and testing needs for verification.
• Review investigations for accuracy and robust rationale before approval.
• Identify product failure modes and potential causes.
• Coordinate and supervise failure investigation activities for lab technicians.
• Support integration of new products into CIS lab and validate test methods.
• Create and present SER/CRB slides.
• Collaborate with Post Market, R&D, Design Assurance, Manufacturing, and Suppliers to determine root cause.

Skills

Structured problem-solving

Failure analysis

Data analytics

Microsoft Office

Written/verbal communication

Education

Bachelor's degree in Electrical Engineering

Master's degree in Electrical Engineering

Tools

Microsoft Office

Job description

Job 3037 - Quality Engineer - Remote

Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.

MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts).

MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.

Applicants must be authorized to work in the U.S. in accordance with applicable law. This position is not eligible for employer-sponsored work authorization now or in the future.

REMOTE

About This Role

Responsible for remediating test methods, work instructions, training and mentoring technicians who work on investigation of return and not-return products. The QE will review result of investigations completed by others for accuracy, completeness, robust rationale for cause of complaint and compliance to SOPs/WIs. QE will also collaborate with other Post Market functions, R&D, Design Assurance, Operations, Supplier Management, and Medical Safety to ensure cause of complaint is well understood and escalated if necessary.

Your Responsibilities Will Include

• Providing leadership role on championing departmental or cross-functional engineering initiatives
• Understanding of failure modes and testing need to confirm them
• Reviewing of all return and non-return investigation work performed by technician to make sure the work is compliant to WIs, complete and supports a conclusion with robust rationale before approving the work
• Understanding the product failure modes and potential causes for the failures
• Coordinating, training and supervising failure investigation activities for lab technicians
• Support integration of new products into CIS lab by creating/validating test methods and test instructions
• Creating and presenting slides for SER/CRB
• Collaborating with other Post Market (CCC/CMC) teams, R&D, Design Assurance, Manufacturing, Supplier and Medical Safety to help determine root cause of complaints
• Monitoring product performance and escalating any non-conformance issues with returned devices
• Creating and maintaining of product performance trends based on UPN and code groupings.
• Investigating trend excursions by doing data analysis to find cause
• Creating, releasing new WI/SOPs in document control system
• Initiating and owning non-conformance investigations
• Training technicians to find root cause of complaints through sound failure analysis techniques

Minimum Qualifications

• Bachelors degree in electrical engineering (preferred) or similar degree, with 4+ years of relevant experience
• Demonstrated structured problem-solving & failure analysis capabilities of electronics systems/components
• Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook
• Great written/verbal communication skills and ability to collaborate with other teams
• Ability to successfully multi-task and be adaptive
• Critical thinking skills and attention to details
• Important: Excellent data analytical skills

Preferred Qualifications

• Masters degree in Electrical Engineering with 2-3 years experience in similar role
• Ability to understand system level functionalities, to devise and validate test methods for failure analysis of systems/components
• Experience in Medical Device industry
• Familiarity with Post Market requirements and systems

Quality Systems Duties And Responsibilities

• Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

MEC does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Medical Engineering Consultants (MEC) and will not be obligated to pay a placement fee.

• Sponsorship is not available for this position

Check us out at www.medicalengineeringconsultants.com

AAP/EEO DFWP

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.