Quality Engineer (SaMD)

Teladoc Health is a global, whole person care company made up of a diverse community of people dedicated to transforming the healthcare experience. As an employee, you're empowered to show up every day as your most authentic self and be a part of something bigger - thriving both personally and professionally. Together, let's empower people everywhere to live their healthiest lives.

Summary of Position

Under the leadership of the Manager of Quality Assurance, the Quality Engineer is responsible for providing Quality input and guidance, and collaborating with cross-functional team including but not limited to Operations, Engineering, Product, Supplier Quality, Supply Chain, Member Quality, and Regulatory to support and drive Medical Device product development, risk management, supplier management, and compliance to internal and external requirements in a fast paced environment.

Essential Duties and Responsibilities

• Contributing to product design with respect to the following principles: design control, change control, risk management, human factor engineering, process validation, and supplier management, and software development lifecycle (SDLC) with sufficient analytical and technical acumen in Quality Engineering.
• Supporting with the design, development, commercialization, and post-launch (full product life-cycle) of electro-mechanical, digital health, and/or diagnostic devices
• Working closely with Product and Technology teams to create and/or execute on design development plans, risk management plans, V&V plans, product test cases, trace matrices, labeling, etc and provide quality guidance in Design & Development deliverables.
• Working with Product and Technology teams to continuously streamline the design and development processes, enabling Teladoc Health to deliver safe and effective new products to members as quickly as possible
• Owning risk management activities for both new design and product/process changes
• Providing quality engineering support and guidance independently during development and sustaining of new product designs and production processes, demonstrating regulatory compliance and adherence to internal QMS requirements
• Reviewing and providing feedback on project decisions and deliverables
• Ensuring that design and/ or production process changes made with suppliers are vetted for potential product performance impact
• Supporting Supplier Quality and Supply Chain activities that require Quality guidance, assessing impacts on supplier changes in design and/ or production processes, reviewing and approving BOM, labeling, supplier validations, Design History File, Device Master Record documentations
• Providing Quality and compliance input for post-market activities, such as hardware changes and software updates, review of customer complaints, and CAPAs
• Partnering with department and project leaders in developing and reporting appropriate performance and Quality metrics
• Applying sound, analytical, systematic, technical problem-solving methodologies in identifying, prioritizing, communicating, and resolving Quality issues
• Supporting internal and external audits
• Other duties as appropriate to support product quality goals and the requirements of the QMS
• Traveling domestically or internationally 1 to 2 times per year

Qualifications Expected for Position

• Bachelor of Science in Engineering - preferably software, mechanical, electrical, or biomedical engineering
• Minimum of 2 years of Quality or Engineering experience in the medical device industry
• Experience with Quality Management Systems including: 21 CFR 820 and ISO 13485 preferred
• Demonstrated experience with ISO 14971 preferred
• Experience in interacting with Notified Bodies and Regulatory agencies, including FDA preferred.
• Passion for finding new, innovative, non-traditional methods for accomplishing goals in a fast paced environment
• Knowledge of medical device design controls, experience in both hardware (IEC 60601 or IEC 61010) and software development IEC 62304 is preferred
• Excellent written, verbal and presentation skills required, including the ability to communicate clearly, succinctly, effectively, and remotely
• Ability to strictly follow policies and procedures when required
• Flexibility to adapt to changing work environments, new priorities, new instructions, delays, or unexpected events
• Skill at managing competing demands, with the ability to change approach or method to best fit the situation

The base salary range for this position is $77,000k- $101,000k. In addition to a base salary, this position is eligible for a performance bonus and benefits (subject to eligibility requirements) listed here: Teladoc Health Benefits 2024. Total compensation is based on several factors including, but not limited to, type of position, location, education level, work experience, and certifications. This information is applicable for all full-time positions.