Sr. Design Quality Engineer

Job description

COMPANY INFORMATION

When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.

Location/Division Specific Information

San Diego, CA

How will you make an impact?

The Sr. Design Quality Engineer will be responsible for supporting New Product Introduction (NPI) programs by providing input to the development teams and authoring or approving Design Controls deliverables. This position is also responsible for providing guidance and coaching for post market product sustaining activities, such as design changes and CAPAs.

Responsibilities

• Provide guidance for product development under Design Controls: User and Product requirements, Functional Specifications, Design Verification, Design Validation, Test Method Validation, Design Reviews, and Design Transfer.

• Identify the opportunities for continuous improvement of the Quality Systems, including Design Controls, document generation, and design testing processes.

• Participate on team projects and assignments, facilitating or leading sub-teams as necessary.

• Provide guidance and decisions on product development and software product development activities to ensure continued compliance with internal procedures, and applicable regulatory and international standards.

• Assess product regulations and standards impact to meet global requirements.

• Work closely with New Product Introduction teams to meet compliance requirements on schedule.

• Ensure all necessary compliance documentation is current and available upon request.

• Maintain awareness of applicable standards and regulations, and monitor activities related to change to the standards and regulation.

• Assist in preparation and/or review documentation required for regulatory submissions.

• Provide leadership to sites to ensure global product compliance requirements are understood.

• Advise Divisional and Business Unit leadership teams regarding strategies related to new and changing regulations and standards, including assessment of business compliance risk.

• Oversee the operations of the Design Compliance group to ensure accurate results, adherence to Company procedures, and timely completion of projects.

• Interface with corporate partners regarding quality issues, audits, and special projects.

• Provide guidance to Manufacturing regarding quality and cGMP issues to ensure compliance with regulated standards.

• Provides direction and guidance to other Design Compliance engineers as needed.

Minimum Qualifications and Requirements

• Bachelor's degree in a Technical or Engineering discipline required.

• Six (or more) years of progressive professional experience in Design Controls or Quality Engineering role.

• Strong knowledge of Design Controls , ISO 14971, ISO 13485, 21 CFR 820.30, EU IVDR, DHF Remediation, Product Requirement Management (Analyze and Update), Impact Analysis, V&V , and regulatory guidelines and their applications.

• Experience in instrumentation and software product development.

• Experience implementing Design for Compliance and training programs.

• Experience in the Lab / IVD / Medical Device field is preferred.

• Excellent interpersonal and communication skills with ability to effectively interface with technical personnel at various levels of the organization.

• Excellent written and verbal communication skills in English.

• Ability to act quickly and decisively.

• Ability to lead.