Design Quality Engineer
Job description
The Design Quality Engineer will be involved in New Product Development (NPI) and will lead quality system and design assurance efforts to ensure compliance with FDA 21 CFR PART 820, ISO 13485 requirements, and EU Medical Device Regulations applicable to a Class III Medical Device company.
Essential Duties and Responsibilities include the following:
Lead Design Assurance activities across the Product Life Cycle
Offer expertise in Risk Management, Design Verification and Validation, Test Method Validation (TMV), Statistical Methods, Process Validation (PV), and other Design Controls elements
Utilize systematic problem-solving methodologies to address quality issues
Keep updated on current regulatory requirements and standards pertinent to medical device development and release
Provide guidance to engineering team members
Support supplier qualification activities
Assist in pilot production setup
Perform additional responsibilities as assigned
Minimum Qualifications
Requires at a minimum a BS in science or engineering with 5+ years of experience in quality management within the medical device or life sciences industry. Experience with US Class III medical devices with cardiac electrophysiology devices is a plus.
SKILLS AND ABILITIES REQUIRED
Demonstrated leadership abilities and the ability to manage a team to achieve company goals.
Must collect and organize diverse information to solve problems, guide the organization, and ensure high product quality.
Must prioritize and plan work activities, set goals and objectives, and organize and schedule other people and their tasks.
Must be able to write clearly and concisely and be able to communicate across various levels of the organization.
Strong knowledge of quality engineering concepts and medical device requirements and the ability to train others on these concepts and requirements.
PHYSICAL DEMANDS
Normal office environment requirements.
Wage range: $80,000–$135,000 annually
Please submit your resume and cover letter to: careers@cardiofocus.com
We do not accept unsolicited resumes from recruiters or employment agencies. Any unsolicited resumes received will be considered the property of CardioFocus, Inc., and we will not be obligated to pay any referral fee unless a prior written agreement is in place.