The Senior Quality Engineer, Medical Device Software, will lead quality assurance activities throughout the product development lifecycle, focusing on new product development for complex medical devices. This role requires expertise in design controls, risk management, and regulatory compliance, with a strong emphasis on collaboration across engineering teams to ensure high-quality, patient-specific solutions at our Bedford, MA facility.
Client Details
My client is a groundbreaking medical technology company focused on transforming the diagnosis and treatment of complex heart rhythm disorders, particularly atrial fibrillation (AF). With locations in New England, the company was established to address the unmet needs in cardiac electrophysiology, enabling clinicians to deliver precise, patient-specific therapies. AF, which affects millions globally, presents significant challenges for effective treatment, as traditional diagnostic tools often fail to capture the intricate patterns of this condition.
To tackle these challenges, my client has developed an advanced mapping technology featuring ultra-high-resolution electrodes. These innovations address two critical obstacles in the field: poor spatial resolution and insufficient sampling density. By enabling unprecedented visualization of complex arrhythmias, this technology empowers clinicians to pinpoint arrhythmia drivers and personalize treatment strategies. Their proprietary solutions aim to improve outcomes by moving beyond the "one-size-fits-all" approach typically seen in cardiac care.
Backed by a combination of private funding and grant awards, the company is built on decades of clinical and scientific expertise. Their leadership team includes prominent electrophysiologists who have driven advancements in understanding and treating cardiac arrhythmias. My client's technologies represent a significant step toward achieving a truly individualized cure for persistent and permanent forms of AF.
Description
The Senior Quality Engineer (Software Medical Devices) Will:
- Represent Quality Engineering in all phases of design activity, including development, verification, validation, transfer, and design reviews for new product development.
- Participate in risk management processes, including analysis and documentation throughout product development.
- Provide quality support to design teams for software, data science, and hardware/systems, ensuring compliance with design control processes and the Software Development Life Cycle (SDLC).
- Support operational quality activities such as material control, process development, inspection, nonconforming material handling, and supplier management.
- Conduct inspections and testing of materials, equipment, processes, and products to meet quality specifications.
- Develop and implement quality system processes to maintain compliance with regulatory and industry standards.
- Lead cross-functional training on quality and compliance best practices while mentoring QA team members.
- Manage internal audit activities and readiness for external ISO 13485 certification audits.
- Expand and maintain knowledge of applicable standards to ensure scalable compliance for product commercialization.
- Collaborate with sustaining engineering teams on continuous improvement initiatives and equipment qualifications.
- Be onsite at our Bedford, MA facility at least 3 times per week
Profile
- Minimum 8 years of experience in Quality Engineering, with a strong preference for candidates entirely from the medical device industry.
- Expertise in new product development within Class II or more complex medical devices.
- Experience working on systems that use input signals to generate data visualization.
- Familiarity with medical device companies serving clients such as Medtronic, Boston Scientific, or Abbott is highly desirable.
- Proficiency in quality processes within startups or smaller organizations is a plus.
- In-depth understanding of FDA regulations and ISO 13485 standards, with a focus on product commercialization readiness.
- Strong ability to collaborate cross-functionally with engineering and quality teams.
- Local to Bedford, MA
Job Offer
- Competitive base salary ranging from $140,000 to $175,000, with additional bonus potential of up to 10%.
- Opportunity to work in a hybrid capacity, with up to two days of remote work per week
- Equity participation through stock options, aligning personal success with the company's growth.
- Generous time-off policy, offering 15 days of paid vacation annually.
- Comprehensive benefits package, covering standard health, dental, and vision plans.
- A chance to contribute to a cutting-edge organization with a mission-driven focus, offering significant professional growth.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.