15 days old

Prin Biomedical Engineer

Medtronic
Northridge, CA 91325
  • Job Code
    210006V2
  • Jobs Rated
    29th

CAREERS THAT CHANGE LIVES:
As a member of the Medtronic Diabetes - Sensor R&D team, this Principal Biomedical Engineer is required to independently plan, execute, and analyze research data to drive development efforts of biosensing sensing technologies and manufacturing with emphasis on glucose sensing. They are expected to provide technical leadership to the broader research organization, and guidance of emerging innovations. The individual will interface with other engineering, regulatory, quality, clinical and marketing teams over the evolution of associated programs.

The Principal Biomedical Engineer will instill rigor and quality in all experimentation and results, providing development guidance and providing decisions to advance sensor programs. The focus will be on integrating various technologies to satisfy program deliverables and requirements through scientific data. There will be strong emphasis on Design for Reliability and Manufacturability (DRM) principles, problem solving methodologies (DMAIC), analytical data methodologies, and process capability analysis. The individual is expected to interpret sensor signal data at various test collection stages (bench top, animal, clinical) and provide scientific recommendations on paths forward.

This individual will be expected to perform independently on their projects as they relate to overall business strategy and product pipeline. There will be occasions when communication to upper management is required through presentations and reports, and the individual must have the ability to effectively convey technical updates to internal and external stakeholders (vendors, sterilization sites, manufacturing, etc.).

Engineers create our market-leading portfolio of innovations. Combine the best of your experience with training and mentorship to move forward. If you want a challenging, energizing, rewarding career that changes lives, join us. Help us bring the next generation of life-changing medical technology to patients worldwide.

We believe that when people from different cultures, genders, and points of view come together, innovation is the result -and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.

BUSINESS DESCRIPTION:

The Diabetes Operating Unit focuses on improving the lives of those within the global diabetes community. As a business, we strive to empower people with diabetes to live life on their terms by delivering innovation that truly matters and providing support in the ways they need it. We're committed to meeting people with diabetes where they are in their journey, always with an aim to make their lives easier. Our portfolio of innovative solutions are designed to provide customers greater freedom and better health, helping them achieve better glucose control, while spending less time managing their disease

A DAY IN THE LIFE:

  • Assume a leading role within multidisciplinary teams to support the development of next generation subcutaneous biosensors with emphasis on glucose sensing
  • Define direction for new sensing modalities, sterilization methodologies, processes, and system integration
  • Apply & instill Best-Known-Methods for robust characterization of various sensor designs
  • Assume responsibility as subject matter expert to represent organization as primary contact for specific projects and initiatives
  • Conduct process characterization design of experiments (DOE) to model the statistically significant critical to quality (CTQ) sensor performance output variability and main effects with respect to process and environmental inputs
  • Apply and interpret characterization DOE models to establish optimal material and process input set points with respect to sensor in-vivo performance
  • Utilize & drive technical skills associated with Six Sigma, Lean, DRM/DFSS and other appropriate continuous improvement techniques
  • Ensure execution of detailed engineering analyses & documentation to support design development and support process transfer
  • Work with other engineers and technicians to execute experimental designs.

    Must Have: Minimum Requirements
    BASIC MINIMUM QUALIFICATIONS
    IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME

    Bachelors degree required with a minimum of 7 years of Engineering experience, or advanced degree with a minimum of 5 years Engineering experience

    NICE TO HAVE:

  • Medical Device Industry Experience
  • Experience working in a cleanroom environment
  • Experience with statistical analysis of data (Ex. Minitab, JMP, etc.)
  • Experience with technical documentation (Ex. laboratory notebooks, publications, engineering reports, IQ/OQ/PQ's, Standard Operating Procedures, test protocols, etc.)
  • Demonstrated experience and track record in applying biosensor first principles and biosensing signals through a DRM discipline
  • Medical device product development cycle
  • Knowledge of regulatory submissions and guidance for medical devices
  • Knowledge about in-vitro and in-vivo testing of subcutaneous medical devices
  • Direct experience in leading characterization, design of experiments and data analysis methodologies (T-test, ANOVA and significance testing at a minimum)
  • Direct experience with sterilization methods and respective requirements used medical device manufacturing: radiation (e-Beam, gamma), autoclave, ethylene oxide, vaporized peracetic acid
  • Applied DMAIC or equivalent Scientific Method problem solving for root cause analysis efforts
  • Direct experience with MATLAB
  • Direct experience with gage R&R studies, demonstrating process capability (Ppk & Cpk), and Qualification procedures (IQ/OQ/PQ)
  • Direct experience with Project Management and relevant tools
  • Related experience providing supporting data to governing bodies (FDA, cFDA, PMDA, LNE GMED, etc)
  • Ability to influence key stakeholders for alignment and drive decision-making
  • Excellent collaborative interpersonal skills
  • Excellent at communication, presentations and solid reporting writing skills
  • Manages multiple large/complex projects, aligning strategically with business needs
  • Highly self-driven, ambitious, accountable and detail-oriented
  • Focus on execution with hands-on, can-do mentality, and creative to find solutions to unexpected challenges

    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.

  • 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.
  • Other examples: Able to lift 25 pounds, Able to view items through microscope, Extended periods of time doing computer-based work

    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 exciting and rewarding place to be.

    We can 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. Help us shape the future.

    EEO STATEMENT
    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.

    This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here:
    http://www.uscis.gov/e-verify/employees

    DISCLAIMER
    The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

    Additional Information

    • Posting Date: Mar 24, 2021
    • Travel: No







  • Jobs Rated Reports for Biomedical Engineer

    Posted: 2021-03-26 Expires: 2021-04-24
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    Prin Biomedical Engineer

    Medtronic
    Northridge, CA 91325

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