Website Abbott Laboratories
Abbott Laboratories
Company : Abbott Laboratories
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
Position Summary:
We are seeking an experienced Senior Development Quality Engineer to join our Structural Heart team at our Menlo Park, CA 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:
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 critical to quality (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 Corrective Action/Preventive Action (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.
Other Responsibilities:
Support regulatory audits as a Subject Matter Expert for Design Controls and other aspects of the quality system.
Support internal and 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.
Required Qualifications:
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.
Ability to multitask, prioritizes and meets deadlines in timely manner.
Strong organizational and follow-up skills, as well as attention to detail.
Ability to travel occasionally (<5%), including internationally.
Preferred Qualifications:
Medical device experience with bioprosthetic heart valve tissue development or manufacturing or other implantable device development.
Previous Development Quality/Design Assurance engineering experience.
ASQ CQE or other certifications.
The base pay for this position is $86,700.00 – $(phone number removed). In specific locations, the pay range may vary from the range posted.