Medical Engineering Consultants (MEC) · 5 months ago
Software Quality Engineer
Maple Grove, MN
Full-time
Onsite
Senior Level, Lead/Staff
9+ years expMedical Engineering Consultants (MEC) supports medical device and pharmaceutical companies by providing resources, knowledge, and expertise. The Software Quality Engineer will develop and maintain software quality engineering methodologies and practices to meet customer and regulatory requirements, while leading initiatives to improve software quality across various projects.
ConsultingMedical DevicePharmaceuticalTraining
No H1B
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 as 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 methodology e.g. project plan, schedule budget etc
Qualification
Required
9 - 11 Years with BS Engineering degree Software Engineering degree preferred
MS degree with 7-8 yrs experience
Has experience leading large teams in Software testing
Has an understanding of Software test review process
Has experience in Software test architecture
Has experience in automation and manual test procedures for medical device environment
Understands IEC-62304 standards in relation to Software verification and validation
Company
Medical Engineering Consultants (MEC)
MEC is a comprehensive solution provider with a full suite of services from consulting and contracting to training and cost savings initiatives.
Founded in 2011Fort Lauderdale, Florida, USA
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Christopher Gustine
Managing Partner
David Campo
Managing Partner
Company data provided by crunchbase