Senior Quality Engineer - Menlo Park, CA

We anticipate the application window for this opening will close on - 28 Feb 2026

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.#
** A Day in the Life
** This is a seasoned individual contributor role responsible for developing, implementing, and maintaining rigorous quality standards and protocols during the sustaining and post-market phases of the product lifecycle. The Specialist serves as a key technical expert, working with limited supervision, who must demonstrate substantial expertise in risk management (e.g., assessing product risk and supporting field actions). This role involves providing design-quality oversight for product changes (including design change analysis and DHF maintenance) and using advanced inspection, testing, and statistical analysis methods to ensure product precision, accuracy, and compliance with all required standards and documentation.

A successful candidate will drive process improvements within the Quality function, manage projects, use specialized knowledge to influence internal stakeholders and external vendors, often requiring travel to design sites within the US, and provide guidance and mentorship. The core mission is to proactively assess, mitigate, and resolve complex technical issues to guarantee product reliability and regulatory adherence.

Responsibilities may include the following, and other duties may be assigned.
* Develops, modifies, applies, and maintains rigorous quality standards and protocols for processing materials into finished products, with a specific focus on the sustaining and post-market phases of the product lifecycle.
* Collaborates with engineering, design, and manufacturing functions to ensure quality standards are established and maintained, including providing Design Quality oversight for product changes, design change analysis, and Design History File (DHF) maintenance.
* Demonstrates strong expertise in risk management by devising and implementing methods and procedures for inspecting, testing, and evaluating product precision and accuracy, and supporting complex risk assessments (e.g., product risk and field action support).
* Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
* Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with all regulatory requirements.
* Required to travel to design and manufacturing sites within the USA to support technical projects, audits, and design quality reviews.
* May specialize in design quality, product evaluation, reliability engineering, and process quality as they apply to managing released product portfolios.
** Required Knowledge and

Experience:

*** Requires a Baccalaureate degree
* Minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience.
** Nice to have:
*** Site transfer experience
* Pharma or combination product
* Risk Management.
** Physical

Job Requirements
** The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles:
While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.…