Senior Product Test Engineer

MiniMed•Los Angeles, CA

5d•$87,000 - $149,000•Hybrid

About The Position

In this exciting role as a Senior Product Test Engineer, you will be responsible for product verification and reliability test planning, designing, developing, and implementing testing methods and equipment for new product development and sustaining projects relating to infusion pump systems. This role is a part of the product Design Verification & Reliability Engineering group, which is in the Mechanical Engineering department of Minimed. The individual will act as a subject matter expert and provide guidance to the business in interpreting and executing against Minimed quality system elements, which include hardware product verification & reliability test related work to ensure compliance. Define test configurations and lab needs for sample testing and specifies tests to be performed. Compile data and defines changes required in testing equipment, testing procedures, manufacturing processes, or new testing requirements. Responsible for writing verification test plans and reports. This individual will ensure that all program work products (e.g., plans, requirements, specifications, tests, test results, traceability, risk management documents, reports) meet Minimed’s quality, reliability, and compliance requirements. This individual will ensure product reliability and verification driven initiatives meet objectives in delivering highest quality products, with supporting tools and processes. This role is hybrid - based out of our Northridge, CA office.

Requirements

Bachelor’s degree with 4+ years of relevant work experience OR Master’s Degree with 2+ years of relevant work experience

Nice To Haves

Bachelor’s Degree in Biomedical, Mechanical, Chemical or Electrical preferred.
Master’s Degree in Engineering, Quality, Regulatory, or related.
Experience working in a regulated industry (e.g., FDA-regulated)
Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1, IEC 60601-2-24 and MDD.
Understanding of the interdependencies of program work products and guide the teams in execution strategy and reviewing the program work products (e.g. plans, requirements, specifications, tests, test results, traceability, risk management documents, reports).
Experience with planning and executing design verification testing, test method development and test method validation (hands on execution experience preferred)
Experienced with statistical analysis of data (e.g. MATLAB, MiniTab, Weibull ++, etc.)
Experienced with data acquisition software (e.g. NI LabVIEW, etc.)
Experienced with fixture design and 3D modeling software (e.g. SolidWorks)
Experience with DFMEA, Accelerated Life Testing, Risk Analysis, Reliability Growth, and/or Demonstration Testing
Working knowledge of electromechanical devices, battery-powered devices, and/or electrochemical reactions
Ability to author technical reports, business correspondence and standard operating procedures.
Ability to apply knowledge and work with development and supply vendors to ensure compliance to Minimed requirements.
Strong verbal and written English communication skills with an ability to effectively communicate at multiple hierarchal levels in the organization.
Ability to multi-tasks, prioritize, meets/exceed deadlines and hold themselves, and others accountable.
Self-Starter with a sharp focus on quality and customer experience.

Responsibilities

Plan and execute large and complex verification and reliability test strategies for medical device product development programs by collaborating and ensuring appropriate key interdependencies are understood and delivered upon by cross functional counterparts from design planning through design transfer for electromechanical hardware product development.
Collaborate with systems engineering and product development teams and apply a systems mindset to develop and evaluate designs from a design input requirements / design outputs perspective that span across multiple product interfaces like electro-mechanical, electro-chemical sensors, embedded firmware and machine learning algorithms.
Develop, coordinate and conduct technical product design verification and reliability demonstration – understand and apply basic product design verification methods & principles for developing design verification, and reliability test strategies.
Lead the development, modification and design review of plans, reports, protocols, data summaries & record.
Use statistical techniques or data analysis such as hypothesis testing, confidence and tolerance intervals, regression, capability analysis, DOEs, etc., to inform design decision making and conclusions for deliverables like test method validations, design characterizations, root cause analysis, and verification and reliability demonstration activities.
Partner and review risk management deliverables like design and process failure modes effects analysis (DFMEA/PFMEA) and Hazard Analysis
Utilize the risk management and robust design principles to understand essential design outputs / critical to quality (CTQ) attributes by partnering with appropriate design team members in early design and development and develop test methodologies to demonstrate effectiveness.
Assist Supplier Quality engineering and purchasing teams in vendor development and component engineering qualification activities as applicable
Participate on project teams and technical review boards and leads change control evaluations.
Coordinate quality decisions between different quality and engineering groups.
Effectively navigate & facilitate project teams with respect to our processes and procedures ensuring the delivery of safe and effective products.
Lead CAPA projects and assisting post market analysis.
Participate in support of external and internal regulatory audits and inspections as applicable.