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Company

Original Job Post

Abbott · 2 days ago

Senior Development Quality Engineer

St Paul, MN

Full-time

Onsite

Senior Level

$73K/yr - $145K/yr

5+ years exp

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Responsibilities

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 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 CTQ parameters and specifications.

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 and CAPA records in a timely and objective manner.

Support product builds in the cleanroom for development and commercial activities.

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, and Process Development to ensure cross functional customer needs are met without creating barriers to development cost, time, and scope.

Qualification

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Medical device engineeringQuality tools/methodologies21 CFR Part 820ISO 13485ISO 14971EUMDRMDSAPProject managementCommunicationTeamworkProblem-solvingAdaptabilityOrganizational skillsMedical Device ExperienceBioprosthetic Heart Valve Tissue DevelopmentManufacturingImplantable Device DevelopmentDevelopment Quality EngineeringASQ CQE Certification

Required

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.

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.

Strong organizational and follow-up skills, as well as attention to detail.

Ability to travel occasionally (<5%), including internationally.

Preferred

Medical device experience with bioprosthetic heart valve tissue development or manufacturing or other implantable device development strongly preferred.

Previous Development Quality Engineering experience.

ASQ CQE or other certifications.