Sr. Quality Engingeer- Software as a Medical Device
Company: Livongo Health, Inc.
Location: Mountain View
Posted on: September 14, 2023
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Job Description:
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 PositionUnder the leadership of the Manager of
Quality Assurance, the Sr. Quality Engineer is responsible for
providing Quality leadership and collaborating with Operations,
Engineering, Product, Supplier Quality, Supply Chain, Member
Quality, and Regulatory to support and drive product development,
risk management, supplier management, and compliance to internal
and external requirements.Role 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)* 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 execute on design development plans, risk
management plans, V&V plans, product test cases, trace
matrices, labeling, etc.* 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* Leading risk management
activities for both new design and product/process changes*
Providing quality engineering support 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, systematic 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 yearQualifications* Bachelor of Science in Engineering -
preferably software, mechanical, or electrical 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* Demonstrated experience with
ISO 14971 required* Experience in interacting with Notified Bodies
and Regulatory agencies, including FDA preferred.* Passion for
finding new, innovative, non-traditional methods for accomplishing
goals* Knowledge of medical device design controls, experience in
both hardware (IEC 60601 or IEC 61010) and software development
(IEC 62304) preferred* Ability to work in a cross-functional team
environment, building rapport and influencing decisions across all
levels of the organization* Excellent written, verbal and
presentation skills required, including the ability to communicate
clearly, succinctly, effectively, and remotely* Enthusiasm for
teamwork and collaboration, with limited supervision* Drive to meet
deadlines and achieve or exceed goals and expectations* Ability to
strictly follow policies and procedures when required, while also
knowing when to think outside the box* 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
situationThe base salary range for this position is $90,000 -
110,000. In addition to a base salary, this position is eligible
for performance bonus, RSU's, and benefits (subject to eligibility
requirements) listed here: Teladoc Health Benefits 2023. 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.#LI-JS3#HybridWhy Join Teladoc Health?A New
Category in Healthcare: ?Teladoc Health is transforming the
healthcare experience and empowering people everywhere to live
healthier lives.Our Work Truly Matters: Recognized as the world
leader in whole-person virtual care, Teladoc Health uses
proprietary health signals and personalized interactions to drive
better health outcomes across the full continuum of care, at every
stage in a person's health journey.Make an Impact: In more than 175
countries and ranked Best in KLAS for Virtual Care Platforms in
2020, Teladoc Health leverages more than a decade of expertise and
data-driven insights to meet the growing virtual care needs of
consumers and healthcare professionals.Focus on PEOPLE:? Teladoc
Health has been recognized as a top employer?by numerous media and
professional organizations. Talented, passionate individuals make
the difference, in this fast-moving, collaborative, and inspiring
environment.Diversity and Inclusion:??At Teladoc Health we believe
that personal and professional diversity is the key to innovation.
We hire based solely on your strengths and qualifications, and the
way in which those strengths can directly contribute to your
success in your new position.Growth and Innovation:? We've already
made healthcare yet remain on the threshold of very big things.
Come grow with us and support our mission to make a tangible
difference in the lives of our Members.As an Equal Opportunity
Employer, we never have and never will discriminate against any job
candidate or employee due to age, race, religion, color, ethnicity,
national origin, gender, gender identity/expression, sexual
orientation, membership in an employee organization, medical
condition, family history, genetic information, veteran status,
marital status, parental status or pregnancy.
Keywords: Livongo Health, Inc., Mountain View , Sr. Quality Engingeer- Software as a Medical Device, Healthcare , Mountain View, California
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