Development Quality Engineer

ICONMA; Saint Paul (MN); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading medical device company in St. Paul, MN is seeking a Development Quality Engineer. In this role, you will lead quality initiatives and ensure compliance with regulatory standards while collaborating with cross-functional teams. The ideal candidate has a background in Engineering or related fields, with experience in the medical device industry and strong problem-solving skills.

Benefits

Health Benefits

Referral Program

Opportunities for growth and advancement

Qualifications

• 0-5 years of engineering experience with quality tools/methodologies.
• Candidates with 0-1 years’ experience may be considered with biomedical or mechanical engineering degrees.
• Experience in medical devices preferred.

Responsibilities

• Lead on-time completion of quality deliverables and business initiatives.
• Support Risk Management activities and Method Validation.
• Authorize and revise procedures to ensure compliance with regulatory requirements.

Skills

Communication

Problem Solving

Organization

Team Leadership

Multitasking

Education

Bachelor’s degree in Engineering, Chemistry, Biotechnology, Life Science, or related field

Job description

Our Client, a Medical Device and Healthcare company, is looking for a Development Quality Engineer for their St. Paul, MN location.

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 Orders and 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 teams including Program Management, R&D, and Process Development to meet customer needs efficiently.
• Support and ensure successful internal & external audit responses and product re-certifications.
• Author and revise procedures, controlled forms, and related documents to ensure best practices and compliance with regulatory requirements.
• Participate in CAPA processes, including failure investigations.
• Comply with FDA regulations, other regulatory requirements, company policies, and procedures. Maintain positive communication with all stakeholders.
• Support divisional initiatives related to QMS, EMS, and other regulatory standards.
• Additional duties may be assigned by management based on current project/business needs.

Requirements:

• Bachelor’s degree in Engineering, Chemistry, Biotechnology, Life Science, or a related technical field.
• 0-5 years of engineering experience with demonstrated use of quality tools/methodologies.
• Strong verbal, written, and interpersonal communication skills.
• Ability to analyze, provide solutions, and develop contingency plans.
• Ability to work in a highly matrixed and geographically diverse environment.
• Effective team player and independent contributor in a fast-paced setting.
• Strong organizational, multitasking, and prioritization skills.
• Candidates with 0-1 years’ experience may be considered if they have relevant biomedical or mechanical engineering degrees and internships.
• Experience in medical devices, especially with bioprosthetic heart valves, valve tissue, implantable devices, or delivery catheters.
• Previous Development Quality/Design Assurance experience preferred.
• Familiarity with ISO 13485, 21 CFR Part 820, ISO 14971, EUMDR, MDSAP, GMP, and GDocP standards.

Why Should You Apply?

• Health Benefits
• Referral Program
• Opportunities for growth and advancement

As an equal opportunity employer, ICONMA supports and encourages diversity and inclusion in the workplace.