Senior Software Quality Engineer - Medical Device; Onsite - Maple Grove, MN Extension

Position: Senior Software Quality Engineer - Medical Device (Onsite - Maple Grove, MN) Possible Contract Extension
Job Description

Job Summary:

Develops, establishes and maintains software quality engineering methodologies, programs, systems, and practices which meet Client, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on a quality initiatives to support departmental, functional, site, divisional and corporate software quality goals and priorities. Provides focused software quality engineering support within new product development, operational, or system/services support. Functional Engineering Roles include:
Software Engineering, IT.

Key Responsibilities:

• Provides leadership role on championing departmental or cross-functional software development/programming/testing/validation/verification quality initiatives.

• Provides project direction, coaching, and mentoring for engineering and technical team personnel.

• Proactively investigates, identifies, and implements best-in-class Software Quality practices.

• Mentor for technical guidance for identifying and resolving software quality issues.

• Identifies and implements effective software quality systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.

• Leads in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external software quality requirements.

• Acts as an effective leader or team member in supporting software quality disciplines, decisions, and practices.

• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving software quality issues.

• Assures the development and execution of streamlined business systems which effectively identify and resolve software quality issues.

• May manage small to medium-sized projects by applying basic project management by applying basic project management methodology (e.g., project plan, schedule, budget, etc.).

Quality Systems

Duties and Responsibilities:

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

Qualifications:

• 9-11 Years of Experience if with a BS Engineering degree (Software Engineering degree preferred)

• 7-8 Years of Experience if with a MS degree

• Has experience leading large teams in Software testing

• Has an understanding of Software test review process

• Has experience in Software test architecture

• Has experience automation and manual test procedures for medical device environment

• Understands IEC-62304 standards in relation to Software verification and validation

Other Details:

• Schedule:
  
  08:00 AM - 04:30 PM CDT

• Work Setup:
  Onsite in Maple Grove, MN

• No Travel Requirements

• Contract Length: 12 Months (September 8, 2025 - September 7, 2026) with Possible Contract Extension