Design Assurance Quality Engineer

Lancesoft; Saint Paul (MN); On-site; USD 85,000 - 120,000; Full time

Job summary

Lancesoft in New Brighton, MN (AVSP) seeks a Design Assurance Quality Engineer II to ensure new or modified medical devices meet quality and regulatory requirements. You will lead risk management, verification/validation planning, and CAPA activities across cross-functional teams to protect patient safety and support product development and manufacturing.

The role supports the Vascular division with DRF compliance, process validation, and DHF integrity, collaborating with Program Management and

Qualifications

• Bachelor's degree in Engineering or a closely related discipline.
• 2+ years of engineering experience with quality tools/methodologies.
• Strong verbal, written, and interpersonal communication.
• Ability to operate in a matrixed, geographically diverse environment.
• Ability to travel occasionally (<10%), including internationally.

Responsibilities

• Lead on-time completion of DA design deliverables and initiatives.
• Define objective customer and product requirements.
• Lead Risk Management from concept to commercialization including FMEA support.
• Support Test/Inspection Method development and Method Validation.
• Plan/execute Design Verification and Validation with cross-functional teams.
• Support manufacturing process development and qualification for new products.
• Coordinate Process Validation and monitor CTQ parameters.
• Review and approve change orders and CAPA records in a timely manner.
• Assist product builds in cleanroom for development and commercial activity.
• Maintain DHF content integrity and regulatory compliance.
• Collaborate with cross-functional teams to meet customer needs.

Skills

Quality tools/methodologies

Communication

Team collaboration

Multitasking

Education

Bachelor's degree in Engineering

Tools

21 CFR Part 820, ISO 13485, ISO 14971, EUMDR, MDSAP

Job description

Title: Design Assurance Quality Engineer II Location: New Brighton, MN Duration: 6 Months

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 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 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 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.


• Participate in 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.