Responsibilities may include the following and other duties may be assigned.
Troubleshoot and characterize performance anomalies in microfabricated electrochemical biosensors through systematic experimentation, advanced analytical techniques, and data-driven analysis.
Develop, record, and perform various root-cause investigations on systems and components to determine failure mechanisms·
Write formal analysis reports, resulting in clear and accurate messaging about analysis findings to both the submitter and a broader audience·
Use working knowledge of failure modes of products to work with technicians and other R&D engineers to assess existing and potential failures·
Work with R&D and quality engineers to identify opportunities for improvements in product quality, reliability, manufacturability, and functionality·
Initiates and leads the efforts on implementing improvements identified as a part of continuous improvement·
Obtain, interpret, and utilize data from formal test, complaint handling, and other document repositories·
Develop new test methodologies to aid in the failure analysis of components and products·
Identify and research component & system failures in the early stages of product development to improve product quality and reliability·
Development of analytical methodologies and equipment acquisitions to ensure strategic failure analysis capabilities for future technologies and products·
Contribute to development of continuous glucose monitoring subsystems as relevant to the group goals
Designs, develops and provides safety testing, repair, and maintenance of biomedical equipment.
Ensures that the biomedical equipment is in compliance with applicable regulatory requirements and quality control standards.
Design studies and conduct research on enzyme reactions and the effects of organic compounds on biological processes.
Participate in activities such as compound screening and compound optimization programs, and developing and running enzyme assays.
Required Knowledge and Experience
Requires a Bachelors degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
Preferred Qualifications
Advanced degree in biomedical engineering, chemical engineering or related engineering field with at least 5 years of experience in Medical Device industry, or an advanced degree with at least 3 years of experience in Medical Device industry.
Demonstrated experience developing electrochemical medical devices within design controls and Quality Management systems; familiarity with FSA requirements, ISO 13485, risk analysis and FMEA.
Demonstrated experience in solving complex failure analysis investigations using structured problem-solving methodologies such as DMAIC, root cause analysis, fault-tree analysis, and hypothesis-driven experimentation.
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
Certification in DMAIC or equivalent Scientific Method problem solving for root cause analysis
Experience with statistical analysis of data (Ex. Minitab, JMP, Matlab, etc.)
Capable of working on multiple projects in a deadline driven environment
Greenbelt in DRM, Six Sigma
Cleanroom procedural experience
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.
Benefits & Compensation
MiniMed offers a competitive salary and flexible benefits package
At MiniMed, we put people first. A commitment to our employees lives at the core of our values: We recognize their contributions. They share in the success they help create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life. Salary ranges for U.S (excl. PR) locations (USD):$112,000.00 - $190,000.00
For roles located in California, Seattle WA, Washington DC, Boston MA, and New York City, the salary range is $124,000.00 - $212,000.00 USD.
Actual compensation may vary based on factors including experience, education, certifications, skills, market conditions, internal equity, and geographic location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
This position is eligible for a short-term incentive called the Short Term Incentive (STI).
At MiniMed, we are committed to supporting the well-being and financial security of our employees. Regular employees working 20 or more hours per week are eligible for a robust benefits package, including health, dental, and vision insurance, as well as access to a Health Savings Account, Healthcare Flexible Spending Account, life insurance, long-term disability leave, and a dependent daycare spending account. In addition, all regular employees enjoy incentive plans, a 401(k) plan with company match, short-term disability coverage, paid time off and holidays, participation in our Employee Stock Purchase Plan, and access to our Employee Assistance Program. Eligible employees may also benefit from our Non-qualified Retirement Plan Supplement and Capital Accumulation Plan, subject to IRS minimum earnings requirements. Please note that “regular employees” refers to those who are not temporary staff, such as interns, and some benefits may not apply to employees in Puerto Rico.
For further details about our comprehensive benefits, we encourage you to visit the link below.
MiniMed Benefits Overview
About MiniMed
MiniMed is a full-stack insulin delivery company dedicated to supporting people living with diabetes through every step of their journey — when and how they need it. For more than 40 years, we’ve been committed to redefining what’s possible: intelligent dosing systems designed for real life, predictive insights that stay a step ahead, and always on support when it’s needed most. At the heart of everything we do is a simple Mission: to make every day a better day for people with diabetes.
Learn more about our business, and our mission here.
It is the policy of MiniMed 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, familial status, membership or activity in a local human rights commission, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state, or local law. In addition, MiniMed will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for MiniMed 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 MiniMed reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. MiniMed 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.
