Senior Design Quality Engineer - Bengaluru, India - Anumana

Description

nFerence Labs: AI platform to reverse engineer biological systems

At nFerence Labs, the "Google of Biomedicine" (See ), where we are building the world's first large-scale computational platform for reverse engineering biology. Just as 20th-century science comprised of the deconstruction of physics unlocking all the engineering and tech applications we are so familiar with, this century is witnessing the deconstruction or reverse engineering of biological systems to unlock all kinds of medical and wellness applications.

We collaborate heavily with premier medical research institutions to get medical insights from patient information including multiple modalities: text, lab data, images, ECGs, etc.

See also our affiliated company developing cardiology AI; where we are conducting clinical studies for cardiovascular algorithms. Our team is a blend of computer scientists and domain experts (biology and medical MDs, and PhDs from premier universities), and we provide an exciting open fast-paced dynamic workplace designed to foster innovative solutions.

Job Summary:

In this role, the Senior Design Quality Engineer provides quality leadership, governance, and engineering best practices to medical device development programs. This is a global role that will oversee multiple concurrent projects to ensure regulatory and quality compliance is maintained throughout the development lifecycle into manufacturing and sustainment. This role will ensure products meet quality standards consistent with internal procedures and acceptance criteria, while meeting all design control and applicable regulatory requirements according to the intended distributed markets.

They will partner with Engineering (R&D), Regulatory, and Operations to establish consistency across product platforms, drive engineering design improvements, and lead implementation of design, manufacturing, supplier and material control related strategies and objectives. This role will drive harmonization and alignment of product lifecycle methodologies and processes across product platforms, sites, and teams to ensure consistency and state-of-the-art Design History Files and Device History Records.

The incumbent will be a strong advocate for product, process, and system quality at all stages of product realization. Additionally, this role will identify and implement improvements within the Quality Management System as part of continual improvement and global objectives.

Essential Duties And Responsibilities:

• Exhibit a strong "quality first" mentality and ensure that product and process quality are held to the highest standard.
• Provide Quality Engineering oversight and direction for multiple concurrent product development and sustaining programs to ensure product & process compliance to all applicable regulations and standards.
• Provide leadership on the product development process, process validation/qualification, and compilation of design related technical and engineering product and process documentation. Partner with R&D teams to implement strategic platform product development approaches to product development.
• Author, review, and/or approve DHF documentation (e.g., strategic planning, product specifications, design verification & validation activities, risk management activities, test method validations, protocols, reports, product transfer to operations, supplier/material qualification activities, etc.)
• Provide quality oversight, review, and approval of qualification documentation and reports. Provide direction during technical and design review activities as a Quality SME. Provide Quality oversight of qualification/validation/design controls activities to other QEs. Review the quality of work completed with the project team to ensure it meets project standards.
• Lead the development and maintenance of product or process risk and hazard analysis in accordance with policies and procedures.
• Ensure the applicable development phase requirements are sufficiently fulfilled and documented within the DHF before allowing the project to proceed within the development process. Escalate and prevent the progression of product development, including release of clinical product, if warranted.
• Represent Quality as the primary interfacing Quality SME with customers to ensure strong partnerships are established and implement solutions for any identified Quality concerns
• Authors and/or reviews reports by collecting, analyzing, and summarizing data; implements corrective actions where necessary as determined by trended data analyses. Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards
• Drive a harmonized product lifecycle program globally within Anumana with the support of Quality leadership. Author and review product development related QMS procedures and work instructions. Proactively identify potential gaps and lead projects to resolve them.
• Partner with organizational leaders and drive quality initiatives, systems, and methods to meet quality objectives. Meet company and departmental goals in the continuous improvement of all products, services and processes, including the QMS.
• Lead and manage QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, audit findings, issue reviews, etc. Provide leadership and direct input on any nonconformance that may occur and drive to closure.
• Establish routine communication strategies for project tracking and prioritization
• Drive continuous quality improvement projects
• Other duties as assigned

Basic Qualifications:

• Bachelor Degree in Engineering, Science or equivalent required. Electrical or Mechanical Engineering concentrations preferred.
• Minimum 5 years of experience in Medical Device Quality & Product Development Lifecycle
• Experience with customer interface and meeting customer expectations
• Experience with Medical Device Design & Development, Verification / Validation Activities, Risk Management, Product Transfer, Process Verification and Validation DHF Activities
• Must have an in-depth knowledge of validations in a Medical Device environment
• Experience with capital equipment and software development desired
• Strong working knowledge of quality systems such as ISO 13485, 21 CFR 820, ISO 14971, IEC 62304, 60601, EU MDR
• Strong project management skills
• Excellent written, critical reading, and oral communication skills
• Must have effective problem solving and interpersonal skills
• Ability to work independently, multi-task and thrive in fast-paced environment
• Strong problem-solving skills including root cause failure analysis methods
• Proficient in statistical software, Windows OS, Microsoft Office: Word, Excel, Power Point.
• Be aware of all relevant SOPs as per Company policy as they relate to this role
• Able to comply with the company's safety and security policies at all times

Preferred Knowledge, Skills and Abilities:

• ASQ certification (CQE or CQA)
• Green or Black Belt certification
• Graduate degree
• Strong project management skills
• Experience with ISO 60601 and ISO 62366 a plus