We anticipate the application window for this opening will close on - 16 Nov 2026 At MiniMed, you can begin a lifelong career of exploration and innovation, while helping make a difference in the lives of people living with diabetes around the globe. You'll lead with purpose, breaking down barriers to innovation for a more connected, compassionate world.
About the Role
We are seeking a highly skilled and experienced Senior Test Engineer to lead the design, development, validation, and sustaining of automated test equipment (ATE) and manufacturing test systems for complex medical devices. This senior-level role is pivotal in ensuring that all manufactured products meet stringent quality, performance, and regulatory standards before reaching patients.
The ideal candidate will bring deep expertise in test system architecture, hardware design, software development, and validation methodologies, combined with a strong understanding of the regulatory landscape governing medical device manufacturing. This individual will serve as a technical subject matter expert (SME), driving innovation in test strategies and collaborating closely with R&D, Manufacturing, and Quality teams to deliver world-class test solutions. Responsibilities may include the following and other duties may be assigned.
Test Equipment Design & Development
- Lead the architecture, design, and development of automated test equipment (ATE), functional test systems, and manufacturing test fixtures for medical devices and sub-assemblies
- Design hardware test systems including custom PCBs, test fixtures, bed-of-nails fixtures, and electrical interface assemblies
- Develop test software and firmware for automated test execution, data acquisition, and result reporting
- Design and implement analog and digital signal conditioning circuits for precision measurement of device under test (DUT) parameters
- Develop test systems capable of evaluating electrical, functional, mechanical, and environmental performance parameters
- Create and maintain detailed test equipment design documentation including schematics, BOMs, software architecture documents, and user manuals
- Evaluate and select commercial off-the-shelf (COTS) test instruments and integrate them into custom test solutions (e.g., NI instrumentation, Keysight, Tektronix)
Test Strategy & Planning
- Define and own test strategies for new products and manufacturing processes, ensuring comprehensive coverage of critical performance parameters
- Develop test coverage matrices linking product requirements to test cases and acceptance criteria
- Collaborate with R&D and Design Engineering to influence Design for Testability (DFT) early in the product development cycle
- Define test escape risk assessments and implement mitigation strategies to ensure product quality
- Lead test equipment qualification and validation (IQ/OQ/PQ) activities in compliance with medical device regulations
- Develop gauge repeatability and reproducibility (Gauge R&R) studies to validate measurement system capability
Software & Automation Development
- Design and develop automated test software using industry-standard platforms such as NI LabVIEW, TestStand, Python, C#, or similar
- Develop test executive frameworks for managing test sequences, data logging, and pass/fail reporting
- Implement database integration for test result traceability and statistical analysis
- Design user interfaces for operator-friendly test station GUIs in compliance with human factors principles
- Develop and maintain software version control and documentation practices in accordance with 21 CFR Part 11 requirements
- Integrate test systems with MES (Manufacturing Execution Systems) and ERP platforms for seamless production data flow
Validation & Compliance
- Lead test equipment validation activities including IQ, OQ, and PQ protocols and reports
- Ensure all test equipment and software comply with FDA 21 CFR Part 820, 21 CFR Part 11, ISO 13485, and applicable standards
- Develop and maintain measurement uncertainty analyses for critical test parameters
- Support regulatory submissions and provide test equipment documentation for FDA and Notified Body reviews
- Participate in risk management activities per ISO 14971 related to test equipment failures and test escapes
- Maintain test equipment calibration programs and ensure traceability to national standards
NPI & Production Support
- Serve as the primary test engineering lead for New Product Introduction (NPI) programs
- Develop test equipment project plans, manage timelines, and communicate status to program leadership
- Support pilot builds and production ramps by ensuring test equipment readiness and operator training
- Provide sustaining engineering support for existing test equipment, including troubleshooting, repairs, and upgrades
- Manage engineering change orders (ECOs) related to test equipment modifications
- Conduct test yield analysis and drive continuous improvement initiatives to improve test efficiency and reduce escapes
Technical Leadership & Mentorship
- Serve as the technical SME for test equipment design and validation across the organization
- Mentor and coach junior and mid-level test engineers and technicians
- Lead technical design reviews for test equipment with cross-functional stakeholders
- Develop and deliver training programs on test equipment operation, maintenance, and troubleshooting
- Represent test engineering in program core teams, design reviews, and leadership presentations
- Stay current with emerging test technologies and industry trends and recommend adoption where appropriate
Continuous Improvement & Innovation
- Champion automation and digitalization initiatives to modernize manufacturing test capabilities
- Drive cost reduction initiatives through test optimization, cycle time reduction, and equipment standardization
- Implement predictive maintenance strategies for test equipment to minimize downtime
- Lead kaizen events and continuous improvement projects focused on test process efficiency
- Develop and track KPIs for test equipment performance, including uptime, test cycle time, and first pass yield
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:
- 8–12+ years of progressive experience in manufacturing test equipment design and development
- Minimum 5 years of experience in a regulated medical device, aerospace, or defense manufacturing environment
- Demonstrated experience leading test equipment design from concept through validation in a regulated environment
- Test Fixture & Hardware Design
- Analog & Digital Circuit Design
- LabVIEW / TestStand Development
- Python / C# / C++ Programming
- IQ/OQ/PQ Test Equipment Validation
- FDA 21 CFR Part 820 / ISO 13485
- 21 CFR Part 11 Software Compliance
- Gauge R&R / Measurement Systems Analysis
- ISO 14971 Risk Management
- COTS Instrument Integration (NI, Keysight)
- MES / ERP System Integration
- PCB Design (Altium, Cadence)
- Six Sigma / Lean Manufacturing
- Machine Vision Systems
- Proven ability to lead complex technical projects from concept through production deployment
- Strong project management skills with experience managing multiple concurrent programs
- Excellent analytical and problem-solving skills with a data-driven mindset
- Outstanding written and verbal communication skills, including presenting to senior leadership
- Demonstrated ability to mentor and develop junior engineering talent
- Strong cross-functional collaboration skills across R&D, Quality, Manufacturing, and Regulatory teams
- Ability to influence without authority in a matrixed organization
- Master's degree in Electrical Engineering, Computer Engineering, or related field
- NI Certified LabVIEW Architect (CLA) or NI Certified TestStand Developer certification
- Six Sigma Green Belt or Black Belt certification
- PMP (Project Management Professional) certification
- Experience with implantable or active medical devices (e.g., insulin pumps, cardiac devices, neurostimulators)
- Knowledge of RF and wireless testing methodologies (Bluetooth, NFC, ANT+)
- Experience with machine vision systems for automated visual inspection
- Familiarity with Industry 4.0 / IoT integration in manufacturing test environments
- Experience with environmental stress screening (ESS) and highly accelerated life testing (HALT/HASS)
- Background in electrostatic discharge (ESD) control and testing
- Knowledge of IPC-A-610 and PCB assembly inspection standards
- Experience supporting FDA inspections or Notified Body audits
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):$97,000.00 - $165,000.00 For roles located in California, Seattle WA, Washington DC, Boston MA, and New York City, the salary range is $97,000.00 - $165,000.00 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).
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.
