Technician II

About the role

The primary focus of this position is Mechanical & Electrical testing of CRM and NEURO division products, including packaging testing, mechanical, and electrical testing of leads, pacemakers, defibrillators, and loop recorders. Testing involves subjecting devices to a wide variety of exposures (environmental, fatigue, implant procedures, electrical, electromagnetic) to ensure designs are robust and meet specifications.

Responsibilities

• Ensure conformance to test plans, work instructions, and industry standards for execution and use of drop, shock and vibe systems, environmental chambers, Instron, electrical test systems, multimeters, generators, oscilloscopes, and other equipment.
• Prepare, set up, troubleshoot, and utilize test instrumentation and complex test set-ups.
• Plan test schedules to manage priorities, maximize equipment run time, and technician time.
• Communicate with management and customers on estimated start dates, status of work in progress, issues, observations, potential disruptions, and competing priorities.
• Work effectively and efficiently in a team environment and as an individual.
• Lead and collaborate on projects, including performing complex tests and providing updates to broader teams and/or customers.
• Use Microsoft Word and Excel for data collection and documenting processes.
• Adhere to industry, company, and department policies, and follow all processes related to testing.
• Communicate and document results clearly and accurately; demonstrate good communication, interpersonal, and technical writing skills.
• Participate in internal and external audits.
• Perform offsite testing on rare occasions, which may require overnight or weekend work.
• Perform a variety of duties in electronic, mechanical, electromechanical, and/or optical areas, including constructing, troubleshooting, calibrating, adjusting, testing, diagnosing, and maintaining equipment, components, devices, or systems.
• Work from schematics, engineering drawings, and written or verbal instructions.
• Operate related equipment; conduct tests and report data in prescribed format.
• Perform calibration and alignment checks; make adjustments, modifications, and replacements as directed; prepare prescribed compounds and solutions.
• Provide technical support in areas such as production, operations, maintenance, safety, testing, process improvement, or product development.
• Gather, maintain, format, compile, and manipulate technical data using established formulae and procedures; perform detailed mathematical calculations.
• For higher levels, suggest and/or make improvements to optimize work processes.

Requirements

• HS Diploma/GED required.
• 2+ years of testing background on medical devices is a plus but not required.
• Completed vocational or technical education.
• Motivated to learn, work, and be part of a high-functioning team.
• Ability to work as a team member and support multiple projects and responsibilities.
• Close adherence to work instructions, policies, procedures, and good documentation practices.
• Knowledge of FDA regulations and ISO/IEC 17025, as well as working in a regulated environment.
• Mechanical, Electrical, and EMC testing experience.
• Demonstrate safe work practices, such as ICD handling and high-voltage tests.
• Solder and assembly experience.
• Familiarity with calibration and metrology services and support.
• Working knowledge of Test Method Validations / Install Qualifications.
• Minimum of 2 years of relevant experience; vocational or technical education or certification in addition to prior work experience may be required.

Differentiating Factors

• Autonomy: Established and productive individual contributor, working under moderate supervision. Performs tests, interprets data, and develops reports.
• Organizational Impact: Performs intermediate technical activities requiring judgment and decision-making. Work consists of technical tasks that are typically routine.
• Innovation and Complexity: Technical problems faced are generally routine but may require interpretation of procedures or policies to resolve. May highlight areas of concerns/problems in own job area.
• Communication and Influence: Communicates typically with internal contacts. Obtains and provides technical information requiring some explanation or interpretation.
• Leadership and Talent Management: May provide guidance and assistance to new or entry-level employees.

Schedule

Work is 100% onsite in Fridley, MN. On rare occasions, offsite testing may occur overnight or weekends.