BrioHealth Solutions · 10 hours ago
Senior Design Quality Engineer
Burlington, MA
Full-time
Onsite
Mid, Senior Level
$110K/yr - $140K/yr
3+ years expBrioHealth Solutions is a global team of Med-Tech professionals focused on patient-centric solutions. They are seeking a Design Quality Engineer to support product development and compliance activities for an active implantable medical device, overseeing all facets of design quality and leading continuous improvement efforts.
BiotechnologyMedicalMedical Device
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
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
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
Qualification
Required
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
Company
BrioHealth Solutions
We are a global team of like-minded Med-Tech professionals focused on patient centric solutions in a collaborative environment leading to excellent outcomes.
51-200 employees
Funding
Current Stage
Late StageTotal Funding
$214.83MKey Investors
HSGBluesail Medical
2025-07-21Series Unknown· $100M
2022-01-25Series D· $100M
2019-06-24Corporate Round· $14.83M
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