Senior Design Quality Engineer

BRIOHEALTH SOLUTIONS INC•Burlington, MA

37d

About The Position

BrioHealth Solutions Inc., Inc. is seeking a Design Quality Engineer to support product development and compliance activities for an active implantable medical device, covering both clinical and commercial needs. In this role, you will oversee and lead all facets of design quality for implantable medical devices and their external peripherals and provide input to continuous improvement efforts.

Requirements

Bachelor’s degree in engineering, science, or related field.
Minimum of 3 years of experience in a medical device quality engineering role.
Demonstrated experience with failure analysis techniques for medical devices.
Strong understanding of risk management principles and regulatory requirements for medical devices (e.g., FDA QSR, ISO 13485).
Excellent analytical and problem-solving skills.
Strong communication and interpersonal skills, with the ability to collaborate effectively across different teams.
Ability to work independently and manage multiple tasks simultaneously.

Responsibilities

Collaborate cross-functionally with product development, engineering, and manufacturing teams to ensure design quality requirements are integrated throughout the product lifecycle, from concept to launch.
Lead and participate in design reviews (DRs), Failure Mode and Effects Analyses (FMEAs), and other risk assessment activities to identify and mitigate potential quality issues early in the development process.
Develop and implement quality plans, test protocols, and acceptance criteria for new product designs, ensuring alignment with industry standards and regulatory requirements.
Provide expert guidance and mentorship to team members on quality engineering principles, methodologies, and best practices, fostering a culture of continuous improvement.
Requirements Traceability: Ensure traceability between design inputs, design outputs, verification/validation activities, and risk controls.
Actively contribute to problem-solving and root cause analysis efforts, utilizing statistical tools and methodologies to drive data-driven decisions and improve product reliability.
Review and approve Verification and Validation (V&V) protocols and reports (including design, software, and process validation) to ensure statistical soundness, adequate sample sizes, and acceptable acceptance criteria.
Oversee the validation of test methods and fixtures used in V&V, including Gauge R&R studies, to ensure measurement system accuracy and reliability.
Design Transfer, lead Quality activities during the Design Transfer activities, ensuring the manufacturing process is capable of consistently producing the design output through process validation and capability studies.
Ensure compliance with QSR/QSMR, ISO 13845, and other relevant global regulations.
Review and approve all elements of the Design History File (DHF) to ensure it is complete, accurate, and compliant for regulatory submissions and internal audits.
Participate in and provide subject matter expertise during internal and regulatory audits (e.g., FDA, Notified Body).
Mentor and train junior engineers and cross-functional teams on quality system requirements, design controls, and risk management principles.
Initiate and support continuous improvement initiatives for complaints and overall business.
Participate in assigned projects (e.g., metrics, change requests, and SOP updates).
Collaborate with key quality and business partners to ensure full investigation of product quality issues.
Contribute to the development and implementation of CAPA plans.
Stay current on relevant regulatory requirements and industry standards.
Contribute to the continuous improvement of the returned product analysis process.