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

Medtronic•Fort Worth, TX

1d•$131,200 - $196,800

About The Position

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. 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.

Requirements

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.
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.

Nice To Haves

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

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.

Benefits

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
Simple Steps (global well-being program)
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)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)