Principal R&D Engineer: NPD for Cranial, Spinal Technologies

Medtronic

Fort Worth (TX)

On-site

USD 131,000 - 197,000

Full time

13 days ago

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Job summary

Medtronic is a global healthcare technology leader seeking an experienced engineer to lead design and development of new products and QMS processes in a fast-paced environment. This role emphasizes cross-functional collaboration with Marketing, Regulatory, Quality, Manufacturing, and R&D to translate needs into clear requirements and robust, cost-effective solutions.

You will develop system architectures, perform analyses, test prototypes, and ensure compliance with ISO 13485 and FDA standards

Qualifications

  • Bachelor’s degree in mechanical engineering or related STEM field.
  • 7+ years technically related experience; or 5+ years with advanced degree.
  • Experience with ISO 13485 and FDA regulated environments is preferred.

Responsibilities

  • Lead cross-functional product development teams and drive engineering decisions.
  • Develop system architectures, interfaces, and technical specifications.
  • Collaborate with Marketing, Regulatory, Quality, Manufacturing, Service, and R&D.
  • Translate stakeholder needs into measurable product and system requirements.
  • Perform analyses and feasibility studies to optimize design performance and cost.
  • Develop and maintain requirements traceability from needs to design outputs.
  • Develop/test prototypes and troubleshoot hardware/software/firmware issues.
  • Lead risk management activities including FMEA and risk controls.
  • Ensure compliance with QMS procedures and regulatory submissions as needed.
  • Mentor junior engineers and support environmental, health and safety rules.

Skills

Technical leadership
Cross-functional collaboration
System architecture
Regulatory awareness
Risk management

Education

Bachelor’s degree in mechanical engineering

Job description

We anticipate the application window for this opening will close on - 8 Sep 2026

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 95,000 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.

A Day in the Life

At Medtronic Neuroscience, we are redefining what's possible in neurological and spinal care, bringing together innovation, expertise, and partnership to improve lives around the world.

At Medtronic CST, we bring together innovative technologies that empower surgeons and improve outcomes in complex spine and cranial procedures.

Check us out on LinkedIn: Medtronic CST

This position takes a leading role in design and development of new products and product improvements. Responsibilities will also include development, implementation and improvement of Quality Management System (QMS) procedures. Leads or supports project planning and project management. Provides engineering and technical support to other functional areas of the company as required.

Primary Responsibilities
  • Technical leadership within cross-functional product development teams and help drive engineering decisions that align with customer needs, business objectives, product strategy, and system-level design goals.
  • Lead the development of system architectures, interface definitions, functional decompositions, and technical specifications to enable successful product realization.
  • Collaborate with Marketing, Clinical, Regulatory, Quality, Manufacturing, Service, R&D teams to translate stakeholder inputs into clear product requirements and technical solutions.
  • Lead the synthesis of user needs, clinical needs, business requirements, regulatory requirements, and technical constraints into measurable and verifiable product, system, and subsystem requirements.
  • Perform engineering analyses, technical trade studies, and feasibility assessments to evaluate alternative concepts and optimize product performance, usability, reliability, manufacturability, and cost.
  • Develop, maintain, and communicate requirements traceability from user needs through design inputs, verification activities, risk controls, and design outputs.
  • Develop and test prototypes, evaluate system performance, and troubleshoot complex technical and integration issues across hardware, software, firmware, disposables, accessories, and manufacturing processes.
  • Analyze engineering and test data to determine whether product designs satisfy functional, performance, reliability, and safety requirements and recommend design improvements when necessary.
  • Support updates and improvements to QMS procedures.
  • Evaluate the impact of external standard changes on products and their DHFs.
  • Lead or support risk management activities including hazard analyses, Failure Mode and Effects Analyses (FMEA), risk assessments, and implementation of risk control strategies throughout the product lifecycle.
  • Provide test reports, drawings, and other requirements to RA necessary for preparing regulatory notifications and submissions 510(k)s and PMAs for domestic and international approvals as required.
  • Define realistic start and finish dates for project-critical action items, submit them to the project team leader, and update the project schedule as needed.
  • Serve as a technical leader with a broad range of duties including determining resource needs, availability or limitations, in advance of issues, to minimize schedule deviations.
  • Identify areas for improvement of manufacturing and lab tooling and technical processes in all project phases and recommend changes to appropriate management. Provides production line support when required.
  • Provide technical training for appropriate Lab and Production personnel as appropriate. Provides process and systems training to other functional areas as necessary.
  • Review appropriate technical literature for necessary background on specific assignments.
  • Perform all activities in compliance with the Quality System.
  • Perform duties in compliance with environmental, health and safety related site rules, policies or government regulations.
  • Mentor and coach junior engineers in technical, soft skills and advise on projects.
Required Qualifications
  • Bachelor’s degree in mechanical engineering
  • 7+ years technically related experience and bachelor’s degree in a STEM discipline OR 5+ years technically related related experience AND an advanced degree.
Preferred Qualifications
  • Experience with motor control theory and implementation, power management, sensors and instrumentation, IEC-60601 standards.
  • Experience with data acquisition and statistical analysis software
  • Experience planning and implementing projects from concept to completion.
  • Experience with design of mechanical and/or electromechanical devices.
  • Experience with manufacture of components for prototypes or production.
  • Experience developing test methods, test execution and report writing.
  • Experienced in QMS procedures, regulations and standards.
  • Experience with Risk Management
  • Experience with computer software: MS Office, ProEngineer, etc.
  • Demonstrated understanding and application of statistical methods/techniques
  • Experience with material selection.
  • Familiar with working in an ISO 13485 and FDA regulated environment
  • Experience with tolerance analysis, GD&T
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 impact. In 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.

Benefits & Compensation
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.

Salary ranges for U.S (excl. PR) locations (USD):$131,200.00 - $196,800.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple 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 match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital 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 law. In 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 find here 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.

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