Development Quality Engineer II

Spectraforce Technologies; Saint Paul Park (MN); On-site; USD 67,000 - 89,000; Full time

Job summary

Spectraforce Technologies, Inc. seeks a Design Assurance Quality Engineer to support vascular device development in Minnesota.

You will ensure products meet requirements, manage risk, and maintain regulatory compliance with FDA, ISO 13485, and 21 CFR Part 820. The role partners with cross‑functional teams to drive quality from concept through commercialization and sustainment, including design verification/validation and CAPA.

Qualifications

• Bachelor's degree in Engineering or closely related field.
• 2+ years of engineering experience with demonstrated use of quality tools/methodologies.
• Strong verbal, written, and interpersonal communication skills.

Responsibilities

• Lead on-time completion of design assurance deliverables and initiatives.
• Define and verify customer, external, and product requirements.
• Lead risk management from concept to commercialization, including FMEA.
• Support method validation, design verification and design validation planning and execution.
• Support manufacturing process development and qualification for new product commercialization.
• Manage Process Validation planning/execution and CTQ parameter monitoring.
• Review and approve document changes and CAPA records.
• Support DHF content completion and regulatory compliance.
• Collaborate with cross-functional teams to meet customer needs and drive cost/schedule goals.

Skills

Quality tools/methodologies

Cross-functional collaboration

Verbal and written communication

Multitasking and prioritization

Travel readiness

Education

Bachelor's degree in Engineering

Job description

Title: Design Assurance Quality Engineer

Duration: 06 Months

Location: St. Paul, MN 55112

The Opportunity

This position works out of our New Brighton, MN (AVSP) location in the Vascular division. Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of Vascular disease.

The individual in this position will ensure 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 products. This position will also support manufacturing processes to meet daily production schedules while enhancing productivity and product quality.

Primary Responsibilities

• Lead on-time completion of project-supported Design Assurance 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 and 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 CTQ parameters and specifications.
• Support, review, and approve Document Change Order and CAPA records in a timely and objective manner.
• Support product builds in the cleanroom for development and commercial activities.
• Maintain high standards for Device History File (DHF) content completion, integrity, and regulatory / standards compliance; collaboratively identifying, communicating, and resolving gaps.
• 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.
• Collaborate with suppliers to drive and implement appropriate changes identified during product development.

Other Responsibilities

• 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.
• Participates in the Corrective Action/Preventive Action (CAPA) process including the investigation of failures or deviations, as required.
• 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.
• 2+ years of engineering experience and demonstrated use of Quality tools/methodologies.
• 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.

• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to travel occasionally (<10%), including internationally.

Preferred Qualifications

• Bachelor's or advanced degree in Mechanical or Biomedical Engineering
• Medical device experience in development or manufacturing or other Cardiovascular catheter device development/manufacturing strongly preferred.
• Familiar with 21 CFR Part 820, ISO 13485, ISO 14971, EUMDR, and MDSAP.