Principal Design Quality Engineer (DHF)

Job Summary:
Principal Design Quality Engineer (Design History Files) - They will be reviewing the entire catalogue of implantable device DHF's to ensure compliance.
Required Qualifications:

• Bachelor's degree in mechanical engineering, Biomedical Engineering or related Engineering field of study.
• Minimum of 6 years of experience in design assurance, quality, or related medical device or regulated industry experience (Experience with Class III Medical Devices preferred).
• Experience in new product development such as driving and creating risk management deliverables (risk management plan/report, hazard analysis, task analysis, dFMEA, etc.), validating test methods, supporting the creation of design requirements, design verification and validation.
• Experience in developing test methods.
• Gap assessment and remediation.
• Experience with a product development team in design quality.
• ISO 13485, ISO 14971, CFRs, and Quality System Regulations understanding & demonstrated use.
• Excellent organizational and planning skills; drives for results.
• Strong communication skills (verbal & written).
• Demonstrated use of Quality tools/methodologies.
• Problem solver, capable of facilitating the problem-solving process.
• Adaptable and effective collaborator in a team environment and in self-directed work.
• Ability to collaborate and work on a global team with peers in R&D, Process Development, Manufacturing and other groups.

Job Description:
We have an exciting opportunity for a Principal Design Quality Engineer supporting development projects within our Cardiology division. This position supports a major product category with high visibility. This person will utilize their established understanding of design controls to contribute to a cross functional team tasked to evaluate the health of existing product design history files and triage the need for remediation.
Responsibilities include:

• In-depth understanding and application of Design Control and Risk Management concepts. Provide quality and compliance input to project teams.
• Provide expertise to assess adequacy of test method validation coverage, documentation and execution.
• Independently and cross functionally assess acceptability of design requirements and risk controls as demonstrated in the design history file documentation. Expectations included demonstrated acumen of user needs, hazard analyses, and design verification deliverables.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.