11 days old

Senior Biomedical Engineer

Medtronic
Northridge, CA 91325
  • Job Code
    21000O48
  • Jobs Rated
    29th
Careers That Change Lives

As a member of the Medtronic Diabetes - Continuous Glucose Monitoring Sensor R&D team, this Senior Biomedical Engineer will assist in development of biosensing technologies and manufacturing with emphasis on glucose sensing. The Senior Engineer will work independently to plan experiments, execute, and analyze research data to assist in driving development efforts. The individual will interface with other engineering, regulatory, quality, clinical and marketing teams over the evolution of associated programs.

A Day in the Life

The Senior Biomedical Engineer will provide technical leadership through competencies in sensing devices and analysis, This individual will conduct rigorous experimentation and generate quality results, providing development guidance and providing decisions to advance sensor programs. The focus will be on integrating various sensing components and 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), develop insights, and provide scientific recommendations on paths forward.

This individual will be expected to perform independently and is responsible for experimental & process design, data analysis, collaborating within and across functions, and writing technical documentation. 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.).

Specific Responsibilities include:

  • Contributing member within multidisciplinary teams to support the development of next generation subcutaneous biosensors with emphasis on glucose sensing
  • Analysis of new sensing modalities, processes, and system integration
  • Apply & instill Best-Known-Methods for robust characterization of various sensor designs
  • Conduct 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
  • Application of data analysis and statistical methodologies to generate insights on sensor performance, drive experiment design and project next steps
  • Assume responsibility as subject matter expert to represent organization as primary contact for specific projects and initiatives
  • Utilize 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

To be considered for this role, please ensure the minimum requirements are evident on your resume.

Bachelors of Science in Biomedical Engineering, Chemical Engineering, Engineering or related sciences with 4+ years of professional experience;

OR

Masters of Science in Biomedical Engineering, Chemical Engineering, Engineering or related sciences with 2+ years of professional experience;

OR

PhD in Engineering in Biomedical Engineering, Chemical Engineering, Engineering or related sciences with 0+ years of professional experience.

Nice to Have

  • Medical Device Industry Experience
  • Experience in applying biosensor first principles and biosensing signals through a DRM discipline
  • Experience with statistical analysis of data (Ex. Minitab, JMP, Matlab, etc.)
  • Experience with technical documentation (Ex. laboratory notebooks, publications, engineering reports, IQ/OQ/PQ's, Standard Operating Procedures, test protocols, etc.)
  • Direct experience in development of biosensors
  • Demonstrated knowledge of sensing fundamentals, mechanisms, chemistry, and materials
  • Direct experience in characterization, design of experiments and data analysis methodologies (T-test, ANOVA and significance testing at a minimum)
  • Knowledge about in-vitro and in-vivo testing of subcutaneous medical devices
  • Experience in signal processing and interpretation of biosensing signals
  • Direct experience with MATLAB and/or Python
  • Exposure to DMAIC or equivalent Scientific Method problem solving for root cause analysis efforts
  • Experience with gage R&R studies, demonstrating process capability (Ppk & Cpk), and Qualification procedures (IQ/OQ/PQ)
  • Experience working in a cleanroom environment
  • Demonstrated ability to manage multiple tasks and projects
  • Experience with Project Management and relevant tools
  • Knowledge of medical device product development cycle
  • Knowledge of regulatory submissions and guidance for medical devices
  • Related experience providing supporting data to governing bodies (FDA, cFDA, PMDA, LNE GMED, etc)
  • Demonstrated written and verbal communication skills
  • Ability to influence key stakeholders for alignment and drive decision-making
  • Self-driven, ambitious, accountable and detail-oriented
  • Demonstrated ability to work independently and within a team-based environment

About Medtronic
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. Help us shape the future.

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)

Additional Information

  • Posting Date: Sep 9, 2021
  • Travel: No






Jobs Rated Reports for Biomedical Engineer

Posted: 2021-09-11 Expires: 2021-10-10
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Senior Biomedical Engineer

Medtronic
Northridge, CA 91325

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