Sr. Development Quality Engineer (Medical Devices) - Intellectt INC

Role: Sr. Development Quality Engineer (Medical Devices)

Location: St. Paul, MN - 55117

Duration: 12 Months on W2Contract

Shift Timings: 8:30 AM to 5 PM

Required Qualifications:

• Bachelor's degree within an Engineering field or a closely related discipline.
• 5-8+ years of Medical Device engineering experience and demonstrated use of Quality tools/methodologies Development Quality experience highly preferred
• Familiar with 21 CFR Part 820, ISO 13485, ISO 14971, EUMDR, and MDSAP.

Primary Responsibilities:

• Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member).
• Lead on-time completion of projects supporting quality and business initiatives.
• Support the definition of objective, measurable, discrete, and verifiable customer requirements, external requirements, and product requirements.
• Lead Risk Management activities including analyzing field data to update Risk Management
• File documents such as, Failure Modes and Effects Analysis (FMEA), Hazard Analysis, and Risk Management Plan/Report.
• Support Test and Inspection Method development including Method Validation activities.
• Accountable for Design Verification and Design Validation planning and execution, including cross-functional root-cause investigation and resolution activities.
• Support manufacturing process development and qualification for design changes.
• Maintain high standards for Device History File (DHF) content completion, integrity, and regulatory / standards compliance; collaboratively identifying, communicating, and resolving gaps.
• Lead and support Corrective Action Preventive Actions (CAPAs) in a timely and objective manner.
• Lead, coach, and mentor junior engineers.
• Build strong collaborative partnerships with cross functional teams including Program
• Management, Research & Development, Regulatory, and Process Development to ensure cross functional customer needs are met without creating barriers to development cost, time, and scope.

Other Responsibilities:

• Support preparing Regulatory Submission documentation and responding to questions from Regulatory Agencies.
• Additional duties may be identified by functional management based on current project/business objectives.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.