Sr. Development Quality Engineer

Spectraforce Technologies
United States, Minnesota, St. Paul
Nov 21, 2024
Title: Sr. Development Quality Engineer Duration: 12 Months Location: St. Paul, MN, 55071 Job Description: 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 Quality deliverables and business initiatives. Support the definition of objective, measurable, discrete, and verifiable customer requirements and product requirements. Lead Risk Management activities including analyzing field data to support Failure Mode Effects Analysis and Hazard Analysis. Support Test and Inspection Method development including Method Validation activities. Support Design Verification and Design Validation planning and execution, including cross-functional root-cause analysis investigation and resolution activities. Support manufacturing process development and qualification for design changes on Commercial products Support Supplier related changes for Commercial products. Maintain high standards for Device History File (DHF) content completion, integrity, and regulatory / standards compliance; collaboratively identifying, communicating, and resolving gaps. Support, review, and approve Document Change Order in a timely manner. Lead, coach, and mentor junior engineers. Be innovative, resourceful, and work with minimal direction. Have excellent organization, problem solving, communication, and team leadership skills. Work effectively with cross-functional teams. Build strong collaborative partnerships with cross functional teams including Program Management, Research & Development, Regulatory Affairs, Supplier Quality, Manufacturing Quality, Manufacturing Engineering and Process Development to ensure cross functional customer needs are met without creating barriers to development cost, time, and scope Support regulatory audits as a Subject Matter Expert for Design Controls and other aspects of the quality system. Support and ensure internal & external audit responses and on-time product re- certifications. Writes and revises SOPs, controlled forms, and related documents to ensure best practices and maintain compliance. Own Corrective Action/Preventive Action (CAPA) investigations. 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. 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. Preferred Qualifications Bachelor's or advanced degree in Mechanical or Biomedical Engineering Prior experience with Cardiovascular medical devices Familiar with 21 CFR Part 820, ISO 13485, ISO 14971, EUMDR, and MDSAP. Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Multitasks, prioritizes, and meets deadlines in timely manner