Design Quality Engineer (m/f/d)

Abbott Automation Solutions GmbH in Hamburg has an opportunity for a Design Quality Engineer, Hardware (m/f/d).

WHAT YOU’LL DO

Primary function is to review and participate in all aspects of product design control for On-Market and In-Development activity in the Medical Device space. It is expected to have a firm understanding of the design input, risk management, design verification, design validation and design output/transfer processes & tools as applied to hardware product development. Effective navigation & facilitation of these processes and procedures is paramount to ensuring product teams deliver safe and effective products.

Main Responsibilities:
Responsible for implementing and maintaining the effectiveness of the quality system.

• Design/Change Control - Hardware responsibilities include participating in the development & review of all design input, risk management, design verification, design validation and design output/transfer related design change activity.
• Engineering Drawings - Review & approve engineering drawings, part structure and associated metadata in our PDM Tool. It is expected to have a firm understanding of engineering drawings and the knowledge of PDM “Product Data Management” tools. Effective navigation & facilitation of these processes and tools is paramount to ensuring efficient review & approval of parts/assemblies.
• Risk Management - Understands and applies basic Risk Management principles. Participates in the development and/or modification of Risk Management Files, FMEA’s, etc.
• Design Verification/Validation – Understands and applies basic Design Verification/Validation methods & principles. Participates in the development, modification and design review of Protocols, Data Summaries & Records.
• Complaint/Defect Evaluation - Investigates complex complaints and/or defects with management oversight. Provides compliant solutions to a variety of complex problems. Ensures compliant documentation related to area of responsibility.
• Documentation - Reviews documentation for accuracy, clarity, consistency, completeness and compliance for projects that vary from low to high complexity. Plans and performs assignments with a wide degree of difficulty.
• Quality System Compliance - Maintains awareness of standards that regulate our industry. Ensures compliance to site level policies and procedures by promptly reporting non-compliance issues to management within Division and Corporation as appropriate. Maintains vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.
• Quality Engineering - Participates on project teams and technical review boards. Coordinates quality decisions between different quality and engineering groups. Effectively navigates & facilitates project teams with respect to our processes and procedures ensuring the delivery of safe and effective products.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required

• B.S. in Mechanical Engineering; Electrical Engineering; Biomedical Engineering; Life Science or closely related discipline is required or relevant combination of education & experience.
• Minimum 2 years’ experience.
• Engineering experience and demonstrated use of Quality tools/methodologies.
• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971 is a plus
• Solid communication and interpersonal skills.
• Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
• Advanced computer skills, including statistical/data analysis and report writing skills.
• Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
• 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 verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to maintain regular and predictable attendance.