Our client is an exciting medical technology company searching for a Principal Design Assurance Engineer. In this role you will lead design assurance activities and initiatives supporting Product Development projects including establishing and improving product design requirements, design review activities, risk management and the development of testing requirements. This role will work with new product development teams to assess product designs as well as working with the team on establishing product design requirements and a strategy for evaluating and demonstrating conformance to the requirements.

Key Responsibilities

· Work with Regulatory, R&D, Engineers, and Product Developers in defining product design requirements and verification/validation methodology and acceptance criteria

· Work with Product Developers in defining system architecture to ensure testability of products

· Lead adherence to Design Controls throughout product lifecycle

· Process owner for product safety risk management (human factors, HW/SW design, process); identifies and implements systemic improvements and supports post-production risk management activities

· Provide technical expertise in review of product design documentation and specifications

· Support Design Reviews

· Review design history files to assure technical accuracy, completeness, and compliance with applicable internal, regulatory and customer requirements

· Provide guidance to continuously improve design and development processes

· Provide guidance to engineers and product developers on compliance to applicable industry/regulatory product design/performance standards and lead activities to verify standards compliance

· Process owner for non-product software and automated systems used in design, operations and manufacturing processes; identifies and implements systemic improvements

· Assist in performing usability engineering activities including defining usability evaluation protocols

· Participate as a member of new product development teams to influence design robustness, reliability, and safety through application of sounds, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving/preventing design quality issues

· Provide input into inspection strategy and plans including working with suppliers on purchased product requirements and development of measurement methodologies

· Lead the transfer of specifications and processes to production during design transfer phase

· Assist in developing design verification and validation plans, protocols, and reports

· Participate in troubleshooting and risk assessment of issues with design team to identify root cause and resolution

· Act as key Subject Matter Expert (SME) during audits and inspections for risk management and non-product software validation processes.

· Participate in continuous improvement of the Quality Management System

· Maintain safe and clean work environment

· Other duties as assigned by the Director of Product Assurance

Qualifications and Skills:

· Excellent written and verbal communication skills and works well individually and in a team with direction, goals, and objectives.

· Ability to develop and maintain relationships, internally and externally. Brings a positive attitude and adapts well in a growing environment.

· Ability to effectively prioritize multiple tasks and deadlines and possess excellent follow through skills. Highly motivated, strong work ethic, and efficient.

· Strong analytical, critical thinking, and problem-solving skills with an attention to detail and organizational goals.

· Basic understanding of electrical and mechanical engineering principles and ultrasound physics

· Experience with verification and validation testing, risk management, design control, and Quality Management Systems

· Experience with medical device software development life cycle

· Experience with FDA Quality System Regulations, ISO 13485 and EU MDR, ISO 14971, IEC 60601 series, IEC 62304, IEC 62366

Minimum Qualifications:

· Advanced degree in a Computer Science, Math, or Engineering (mechanical engineering preferred) related field and five years of relevant experience in the medical device field, or bachelor's degree and a minimum of 10 years of relevant experience