Careers That Change Lives
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.
A Day in the Life
Provides engineering support for new product design and development, existing product modifications, process design, and performance evaluation.
Uses computer-assisted engineering and design software and equipment to perform engineering and design tasks.
Develops and tests prototypes from design specifications, defines processes to properly make and assemble the product and optimizes process.
Develops product and process verification and validation, test protocols and reports in compliance with design control requirements.
Analyzes test data and reports to determine if designs meet functional and performance requirements.
Support updates and improvements to QMS procedures.
Evaluate the impact of external standard changes on products and their DHFs.
Leverage knowledge of Risk Management, Regulations, Procedures to ensure continued product compliance.
Provides 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.
Determines realistic start and finish dates for action items imperative to project completion on project schedule and submits to project team leader. Updates project schedule as required.
Serves as a project leader with a broad range of duties including determining resource needs, availability or limitations, in advance of issues, to minimize schedule deviations.
Identifies areas for improvement of manufacturing and lab tooling and technical processes in all project phases and recommends changes to appropriate management. Provides production line support when required.
Provides technical training for appropriate Lab and Production personnel as appropriate. Provides process and systems training to other functional areas as necessary.
Reviews appropriate technical literature for necessary background on specific assignments.
All activities must be performed in compliance with the Quality System.
Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.
Must Have: Minimum Requirements
Bachelor’s degree in Mechanical Engineering or Biomedical Engineering
4+ years related experience with bachelor’s degree. 2+ years related experience with advanced degree.
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.
Basic understanding of statistical methods
Nice to Have
Advanced degree. Masters or Doctorate.
Familiar with working in an ISO 13485 and FDA regulated environment
Experience with material selection
Understanding and application of statistical methods
Experience with data acquisition and statistical analysis software
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services 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 exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives.
Physical Job Requirements
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. (ADA-United States of America)
Travel requirement: Less than 10%