Senior Design Quality Engineer CST Fort Worth, TX (Onsite)
Fort Worth, TX - USA
Job Summary
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain restore health and extend life. Our 95000 employees work across more than 150 countries to put patients first developing innovative medical technologies that improve the lives of 72 million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose growth and impact.
As one of three comprehensive portfolios at Medtronic Neuroscience is dedicated to improving the lives of people living with neurological disorders spine conditions and chronic pain. Guided by our Missionto alleviate pain restore health and extend lifewe develop technologies and therapies that help people regain function reduce pain and return to the activities that matter most.
Our Cranial & Spinal Technologies (CST) Operating Unit develops and delivers an integrated ecosystem of spinal implants navigation and robotic guidance systems advanced imaging and data-driven planning tools for complex spine and cranial procedures. Platforms such as AiBLE connect these technologies to enhance surgical precision streamline workflows and support improved patient outcomes across the globe.
Check us out on LinkedIn: Medtronic CST
This position is not eligible for immigration sponsorship. Applicants must be authorized to work in the country of employment without sponsorship.
A Day in The Life:
In this exciting role as a Senior Design Quality Engineer you will partner with cross-functional teams to ensure quality is integrated throughout the product development lifecycle from concept through commercialization and sustaining engineering. You will work closely with R&D Regulatory Clinical Operations and Manufacturing to support Design Quality execution risk management design verification and validation and compliant product development. This role plays a critical part in ensuring products meet quality regulatory and customer requirements while supporting continuous product improvements and successful design transfers to manufacturing.
Key Responsibilities:
Partner with cross-functional teams to integrate Design Quality requirements into product development and lifecycle management activities.
Support Design Quality execution from concept through commercialization design changes and sustaining engineering.
Contribute to risk management activities including risk identification assessment mitigation and traceability throughout product development.
Support design verification and validation activities to ensure products meet quality safety and regulatory requirements.
Develop and maintain objective evidence design documentation and Design History File (DHF) records to support compliant product development.
Apply quality system and regulatory requirements to design changes product modifications and lifecycle management activities.
Support design transfer activities by partnering with Operations and Manufacturing to ensure quality requirements are effectively implemented.
Develop apply and maintain quality standards inspection methods testing protocols and quality documentation.
Collaborate with Engineering and Manufacturing to establish quality processes and ensure product and process compliance.
Perform quality analysis inspection planning statistical analysis and support corrective and preventive actions to improve product quality and reliability.
Support quality activities involving suppliers externally developed components and manufacturing processes to ensure compliance with applicable standards.
Location: Fort Worth TX (Onsite)
Onsite: At Medtronic we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. Were working onsite 4 days a week to drive performance foster an environment of belonging and collaborate to inspire as we engineer the role will require <10% of travel to enhance collaboration and ensure successful completion of projects.
Minimum requirement:
Bachelors degree in Engineering or Technical field with minimum of 4 years of relevant experience OR
Masters degree in Engineering or Technical field with minimum of 2 years of relevant experience OR
PhD with 0 years of relevant experience
Nice to Have (Preferred Qualifications):
Experience in medical device or other highly regulated industry.
Experience supporting combination products including drug delivery systems biologics or other combination device technologies.
Experience with product lifecycle management sustaining engineering and design changes
Knowledge of Design Controls Design Verification & Validation (V&V) and Risk Management (ISO 14971).
Familiarity with FDA Quality System Regulation (21 CFR Part 820) ISO 13485 and global medical device regulations.
Exposure to Design History Files (DHF) traceability and technical documentation.
Experience with statistical analysis root cause investigations and quality improvement methodologies.
Experience supporting design transfer and manufacturing readiness activities.
Strong cross-functional collaboration skills with R&D Regulatory Clinical Operations and Manufacturing teams.
For Baccalaureate degrees earned outside of the United States a degree that satisfies the requirements of 8 C.F.R. 214.2(h)(4)(iii)(A) is required.
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. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
U.S. Work Authorization & Sponsorship
At Medtronic we are committed to fostering an environment where employees can thrive and make a meaningful alignment with our enterprise-wide workforce planning approach U.S. work authorization sponsorship (H-1B TN J etc.) is offered exclusively for Principal-level roles and above where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
Recruitment Fraud Alert
We are aware of phishing scams targeting job seekers. Please keep the following in mind:
Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @ email addresses.
Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.
If you receive a suspicious message claiming to be from Medtronic do not respond click links or open attachments.
If you have any questions concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic please contact us immediately at .
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits resources and competitive compensation plans designed to support you at every career and life stage.
The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees:Incentive plans 401(k) plan plus employer contribution and matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital Accumulation Plan (available to Vice Presidents and above or subject to IRS earning minimums).
Regular employees are those who are not temporary such as interns. Temporary employees are eligible for paid sick time as required under applicable state law and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and/or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by federal state or local addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic Inc. (Medtronic) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County you can findhere a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Required Experience:
Senior IC
About Company
About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an excit ... View more