Job Title:
Development Quality Engineer II
Location: St. Paul, MN 55117
Duration: 12 Months
Position Summary:
We are seeking a
Development Quality Engineer II to join our Structural Heart team at our St. Paul, MN location. The individual in this position will assure new or modified products conform to requirements and establish compliance with the quality system. This position is responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. This position will support new product development projects as well as support sustainability of commercially released product. This position may also support manufacturing processes to meet daily production schedules while enhancing productivity and product quality.
Primary Responsibilities:
- Lead on-time completion of project supported quality deliverables and business initiatives.
- Support the definition of objective, measurable, discrete, and verifiable customer requirements, external requirements, and product requirements.
- Lead Risk Management activities from product Concept through Commercialization, including analyzing field data to support new product development, and support Failure Mode Effects 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 new product commercialization and product changes.
- Accountable for Process Validation planning and execution, including active cross-functional root-cause analysis investigation and resolution activities.
- Identify and implement effective Process Control and monitoring of critical to quality (CTQ) parameters and specifications.
- Support, review, and approve Document Change Order and Corrective Action/Preventive Action (CAPA) records in a timely and objective manner.
- Support product builds in the cleanroom for development and commercial activities.
- 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, and Process Development to ensure cross functional customer needs are met without creating barriers to development cost, time, and scope.
Other Responsibilities:
- Support and ensure internal & external audit responses and on-time product re-certifications.
- Author and revise procedures, controlled forms, and related documents to ensure best practices and compliance to regulatory requirements.
- Participate in CAPA process including the investigation of failures, as required.
- Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. Maintain positive and cooperative communications and collaborate with all levels of employees, customers, contractors, and vendors.
- Support all divisional initiatives as identified by divisional management, including support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Additional duties may be identified by functional management based on current project/business objectives.
Education:
- Bachelor's degree within Engineering, Chemistry, Biotechnology, Life Science, or other technical field.
Required Qualifications:: 0 - 1 years' experience will be considered for candidates with biomedical and mechanical engineering degrees, especially with medical device internships. 2 - 5 years' experience preferred and open to candidates with an engineering or science degree.
Preferred Qualifications:
- Medical device experience, including internships or Co-op, specifically with bioprosthetic heart valves, valve tissue development or manufacturing or other implantable devices, or delivery catheters.
- Previous Development Quality/Design Assurance engineering experience
- Previous experience working with any or all of the following:
- ISO 13485 Medical Devices - Quality Management System
- 21 CFR Part 820 FDA Quality System Regulations
- ISO 14971 Medical Devices - Application of Risk Management
- EUMDR
- MDSAP
- Good Manufacturing Practices and Good Documentation Practices
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Spectraforce Technologies
Jun 03, 2025