The Senior Principal Design Assurance Engineer will serve as a subject matter expert by providing design quality support for new product development and sustaining projects. This position will act as a subject matter expert and provide guidance to the business in interpreting and executing against the company’s Quality Management System and against domestic and international regulatory requirements to ensure compliance. Responsible for ensuring that all system-level project work for new products and for product changes (e.g., plans, requirements, specifications, protocols, tests methods, test results, risk management documents, reports) meet the company’s quality and compliance requirements. This role will ensure design assurance-driven initiatives meet objectives in delivering the highest quality products, with supporting tools and processes. The Senior Principal Quality Engineer reports to the Design Assurance Manager.
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:
Constantly evaluates the Design Control, Change Control, and Risk Management procedures to ensure conformity to the regulations and ensures state of the art compliance; creates and/or revises documentation to achieve this goal.
Works with R&D, Engineering, Manufacturing, Regulatory functions to define requirements for new product development. Partners with R&D to determine and define design inputs, design outputs, and design input/output relationships.
Participate and lead new product development phase reviews and design reviews.
Create and support the development and validation of new test methods.
Evaluate the impact of any new product or changes to existing products on regulatory applications.
Supports Sustaining Engineering for design and process changes to commercialized product.
Ensure compliance of project activities to appropriate regulations and standards. A nonexclusive list of such regulations and standards would include ISO 13485, ISO 14971, 21 CFR part 820, CMDR and EU (MDD and MDR) regulations.
Will fulfill the position of independent reviewer during the design review process.
Assists with the selection and qualification of new and/or existing suppliers; this may include execution of Quality Management System supplier audits.
Drives the Risk Management process, leading the creation of deliverables such as Hazard Analyses, DFMEA, URRA, and PFMEA.
Supports Regulatory Affairs in preparing submissions and responding to submission questions.
Will be the liaison between the R&D team, suppliers and manufacturing to ensure a smooth transition of the design. It is involved through all phases of Design Development and it is involved in the IQ, OQ, PQ, Design verification, Design Validation, supplier approval and development.
Use of statistical techniques for data analysis for deliverables such as design verifications and process validation.
Provides mentoring, guidance, and/or work direction for more junior level engineers.
Other duties as assigned.
KNOWLEDGE, SKILLS AND ABILITIES:
Excellent presentation, written and verbal communication skills, and interpersonal skills; ability to work in a team environment.
Ability to work proactively and independently.
Independently determines and develops strategies and solutions.
Ability to define, organize, and manage individual and team tasks; provide direction to core and extended team members.
Strong understanding of design controls, risk management, and new product development processes.
Proficient in technical report writing and review.
Experience in statistical software packages (e.g. Minitab, Statistica, NCSS, etc.).
Proficiency in using Microsoft Office Applications required (MS Word, MS Excel, MS PowerPoint).
Project management and problem-solving skills are highly preferred.
EDUCATION AND EXPERIENCE:
Bachelor’s degree in an engineering or science field required; advanced degree preferred.
10+ years of experience in medical devices.
Possession of relevant professional certifications related to quality systems and compliance for medical industry; ASQ and RAPS are preferred.
New World Medical, Inc. (NWM) is an Equal Opportunity Employer. NWM takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.