Technician II

Planet Pharma; Minneapolis (MN); On-site; USD 52,000 - 72,000; Full time

Job summary

Planet Pharma is seeking a Technician to perform mechanical, electrical, and EMC testing of CRM and NEURO devices. You will work on test plans, equipment calibration, data collection, and documentation in a regulated environment.

Responsibilities include setting up and troubleshooting test rigs, coordinating test schedules, and communicating status to teams and customers. Onsite work in Fridley, MN with occasional offsite testing may occur.

Qualifications

• Minimum 2 years testing experience; medical devices preferred.
• HS Diploma or GED required; vocational/technical education or certification encouraged.
• Familiarity with FDA regulations and ISO/IEC 17025 in a regulated environment.
• Proficient with test instrumentation and documenting results.
• Ability to read schematics and engineering drawings.
• Strong communication and documentation skills.

Responsibilities

• Ensure conformance to test plans and industry standards for testing equipment and procedures.
• Prepare, set up, troubleshoot, and use test instrumentation and complex test setups.
• Plan test schedules to optimize equipment run time and technician time.
• Communicate project updates, status, and issues to management and customers.
• Lead and collaborate on projects; perform complex tests and report results.
• Proficient in Microsoft Word and Excel for data collection and documentation.
• Participate in internal and external audits.
• Work 100% onsite in Fridley, MN; some offsite testing may occur.

Skills

Medical device testing

Documentation

Team collaboration

Quality systems

Education

HS Diploma/GED

Vocational/technical education

Tools

Instron

Oscilloscopes

Multimeters

Environmental chambers

Soldering equipment

Calibration equipment

MS Word / Excel

Job description

The primary focus of this position will be Mechanical & Electrical testing of CRM and NEURO divisions products. This may include packaging testing, mechanical, and electrical testing of leads, pacemakers, defibrillators, loop recorders. Testing is focused on subjecting our devices to a wide variety of exposures (environmental, fatigue, implant procedures, electrical, electromagnetic) and ensuring designs are robust and meet specifications.

Responsibilities may include the following and other duties may be assigned.

• 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 and equipment, multimeters, generators, oscilloscopes, etc.
• 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 the estimated start date, 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 the broader teams and/or customers.
• Proficiency with computer skills, Microsoft Word and Excel for data collection and documenting processes.
• Proficient in adhering to industry, company, and department policies.
• Ability to read and follow all processes related to testing.
• Good communication, interpersonal and technical writing skills; communicate and document results clearly and accurately.
• Participate in internal and external audits.
• Work is 100% onsite in Fridley, MN
• On rare occasions, perform offsite testing which may occur overnight or weekends.
• HS Diploma/GED required

Ideal Candidate will:

• 2+ years testing background on medical devices a plus but not required
• Completed vocational or technical education
• Motivated to learn, work, and be part of a high functioning team
• Work as a team member and support multiple projects and responsibilities
• Pay 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, for example ICD handling and high voltage tests
• Solder and assembly experience
• Familiar with calibration and metrology services and support
• Working knowledge of Test Method Validations / Install Qualifications

Responsibilities may include the following and other duties may be assigned. Performs a variety of duties in the electronic, mechanical, electromechanical, and/or optical areas. Constructs, troubleshoots, calibrates, adjusts, tests, diagnoses, and maintains equipment, components, devices, or systems. Works from schematics, engineering drawings and written or verbal instructions. Operates related equipment; conducts tests and reports data in prescribed format. Performs calibration and alignment checks; makes adjustments, modifications, and replacements as directed; prepares prescribed compounds and solutions.

TECHNICIAN SUPPORT CAREER STREAM

Provides technical support in areas such as production, operations, maintenance, safety, testing, process improvement or product development. Uses schematics, diagrams, written and verbal descriptions or defined plans to perform testing and troubleshooting on electronic or mechanical components, equipment or systems. Gathers, maintains, formats, compiles, and manipulates technical data using established formulae and procedures, and performs detailed mathematical calculations. For higher levels, may suggest and/or make improvements to optimize work processes.

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 decisionmaking . 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 problems . May be required to 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.

Required Knowledge and Experience

Requires basic job knowledge of systems, techniques and procedures obtained through prior work experience or education. Requires minimum of 2 years of relevant experience; may require vocational or technical education or certification in addition to prior work experience.