Design & Development Quality Engineer II

JOB SUMMARY

The Engineer II, Quality Design & Development is responsible for providing support to product development teams and sustaining manufacturing/operations teams.  This individual will be expected to apply design control principles and techniques for medical devices. As a member of one or more cross-functional teams, this individual will ensure products are designed and developed in accordance with applicable regulatory requirements, customer requirements, and company policy.

ESSENTIAL RESPONSIBILITIES

• Perform Design Quality Engineering activities throughout the design, development and production of medical devices to ensure compliance to company’s Design Control procedures and regulatory requirements (specifically FDA 21 CFR 820 and ISO 13485).
• Demonstrated understanding and application of regulations and standards (specifically ISO 14971, 2017/745 EUMDR, IEC 60601, IEC 10993)
• Create, review and/or approve technical Design Control documentation to facilitate design, development, and product verification testing of medical devices in collaboration with cross-functional engineering teams.
• Create and execute Quality Plans for Product Design and Development projects.
• Represent Quality Engineering in technical design and phase end reviews.
• Develop and perform Design of Experiments (DOE).
• Develop and validate test methods.
• Develop sampling plans and acceptance criteria for product testing and inspection methods using appropriate statistical techniques.
• Lead and/or participate in risk management activities, develop Risk Management Plans and Reports, perform Hazards Analysis and FMEAs (Failure Mode Effects Analysis) to evaluate and ensure product safety and functionality.
• Conduct and/or support root cause investigations, develop and implement corrective and preventative actions for quality system and product related nonconformance's.
• Support quality system improvement initiatives and CAPA’s.
• Responsible for the assessment of technical standards, labeling and technical file requirements.
• Responsible for the assessment of component and system level specifications relative to customer needs and product performance specifications.
• Perform requirement flow down analysis on critical to quality product performance specifications down to components and process.
• Apply Design for Reliability and Manufacturability tools and techniques.
• Support for multiple projects, balancing priorities and resources to meet both project and management expectations.
• Prepare reports required by the project or department management.
• Lead and/or participate in reviews and communications with customers.
• Reliable, consistent and punctual attendance is an essential function of the job
• Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

QUALIFICATIONS

• B.S. Degree in Engineering or associated fields, or equivalent industry experience.
• 2 years’ experience in design, quality, or reliability engineering in medical devices.
• Knowledge of quality assurance and regulatory compliance including Quality System Standards and Regulations.
• Knowledge of product development processes and methods.
• Knowledge of systems engineering discipline, Technical Standards, Hazard Analysis and Failure Mode and Effects Analysis (FMEA), Qualification, Test Method and Process Validation.
• Knowledge in the application of risk management
• ASQ Certification preferred

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.