Senior Design Quality Engineer

Defibtech is seeking a Senior Design Quality Engineer responsible for leading and supporting product and process quality for a medical device company in support of class III devices in a cGMP environment. In addition, the Senior Design Quality Engineer will work to cross-functionally lead and implement quality engineering projects and programs supporting manufacturing and product lifecycle activities across all project lines in support of Defibtech's mission to provide high-quality medical devices. This position is based onsite at our Guilford, CT headquarters.

Core Responsibilities:

• Represents the Quality function in various roles such as product support and lifecycle management, including post market activities.
• Applies deep knowledge of Design Control principles and quality engineering techniques to positively influence new product development efforts, including those for design inputs, specification development, verification, design and process validation, and risk management.
• Serves as the Core Team lead for Quality Assurance in New Product Development
• Provides quality input in assisting with generating design plans, reviewing design inputs, outputs, verification, validation, design transfer, phase reviews and/or scale up strategies.
• Acts as a subject matter expert on the Design Control Process, Quality Systems and Quality Engineering methodologies.
• Successfully addresses complex engineering issues where analysis of situations or data requires an in-depth evaluation of variable factors supporting design and post market requirements, such as CAPAs, audits, complaints and sustaining activities.
• Provides guidance to engineering staff and other employees to ensure that quality system requirements are being met in an effective manner to achieve quality by design.
• Generates plans, drafts reports, and reviews reports and files for accuracy and completeness and provides guidance on compliance and procedures. Supports maintenance of Design History File.
• Provides input to design and manufacturing engineering project deliverables including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.
• Assists in the development and maintenance of company procedures for design control, change management, risk management, process validation and related areas of the quality management system.
• Demonstrates Defibtech's values on the job. Promotes and participates in continuous improvement.
• Actively supports compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including but not limited to FDA, Quality Systems Regulations, safety regulations and applicable statutes).

Qualifications / Requirements:

• Bachelor's Degree with at least 5 years of related work experience or the equivalent combination of education, experience and/or training.
• Preferred candidates will have a bachelor's degree in an engineering discipline and 7+ years of experience.
• A minimum of 5 years in quality within the medical device industry is required. Preferred candidates will have more than 3 years of experience in a New Product Development environment from concept development through product launch.
• ASQ (e.g., CQE, CMQ/OE, etc.) and/or Lean and/or Six Sigma certification are highly preferred.

Knowledge, Skills & Abilities:

• Knowledge of FDA Regulations and Medical Device Software Development Lifecycle.
• Knowledge of reliability, maintainability, and risk management, including key terms and definitions, systems design, assessment tools, and reporting.
• Technical knowledge of medical device verification and validation.
• Understanding of FDA QSR Part 820, ISO 13485, ISO 14971, EU MDD / EU MDR.
• Understanding of a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements.
• Knowledge of inspection and audit process including types of audits, planning, preparation, execution, reporting results, and follow-up.
• Strong interpersonal, communication, influencing, and negotiation skills with the ability to work on teams and individually.
• Detail oriented with strong analytical and problem-solving skills.
• Demonstrated ability to lead others within small project or investigational environments.
• Excellent organizational skills and the ability to manage responsibilities in a fast-paced environment
• Proficient with Microsoft Office Suite or related software.

Work Environment and Physical Demands:

• Work is primarily based in an office setting and frequently supporting light manufacturing setting.
• Physical demands are primarily sedentary with frequent sitting at a desk working on a computer, standing and short durations of walking throughout location(s)and lifting up to 10lbs.

Compensation and Benefits:

• Defibtech offers competitive salaries and a comprehensive benefits package including core health benefits, company-paid disability, and a company matching 401k plan.
• Defibtech promotes a challenging, collaborative, and friendly culture that is centered around our values: Passion, Innovation, Integrity, and Ownership.
• Defibtech is supportive of work balance providing company gatherings to add fun and generous paid time off and flexibility for employees to manage time and responsibilities.
• Defibtech is committed to empowering and supporting our employees in their philanthropic efforts through donation programs and time off for volunteerism.

Defibtech is committed to a diverse workplace and is an Equal Opportunity/Affirmative Action employer and E-Verify Company. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

The above description of core responsibilities and qualifications are intended to describe the general nature and level of the work being performed, but they are not an exhaustive list of all the required responsibilities and skills of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Defibtech endeavors to make www.defibtech.com accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact Human Resources at 203.453.6654. This contact information is for accommodation requests only and should not be used to inquire about the status of applications.