Principal Technician

Abbott • Saint Paul, MN

11d • Onsite

About The Position

Support engineers and project teams with tasks and responsibilities from concept feasibility through DV&V. Coordinate daily product testing workflow, while ensuring all documentation is complete and accurate, including all training files. Provide support to all product testing employees and communicate all trends and problems to Management. Perform duties to prototype and/or test products, meeting FDA, OSHA, GMP/MDD/MDR and ISO compliance requirements. Maintain a safe and effective work environment for the completion of product testing. Work collaboratively with teams to develop/conduct/report on technical experiments and developments.

Requirements

• Vocational / Technical education or equivalent work experience.
• Minimum 7 years’ experience within medical device industry in a technical role
• Ability to read and create diagrams, charts/graphs, and schematics.
• Understanding of FDA, QRS(GMP)/MDD and ISO standards; ability to learn by exposure to industry standards.
• Strong leadership skills
• Ability to prioritize and control work-flow
• Experience in understanding and executing test protocols, procedures and validations associated with product development
• Knowledge of Quality Systems and supporting documentation
• Microsoft Office experience

Nice To Haves

• Strong mechanical aptitude including experience with the assembly of new medical device concepts and knowledge of manufacturing techniques.
• Technical and/or verifiable on-the-job training in the use of typical shop equipment including drill presses, mills, lathes, pressurized air tools, sheet metal fabrication, threading/tapping, etc.
• Technical and/or verifiable on-the-job training in part measurement and inspection techniques.
• Knowledgeable and experienced in medical device construction techniques such as reflowing, swaging. soldering, brazing, welding and other catheter, guidewire, and sheath construction techniques.
• Experience with 3D printing
• Experience in test development and DOE

Responsibilities

• Train to all required testing procedures and ensure continuous improvement
• Ability to communicate testing concerns/issues with Engineers and Management
• Ability to interface with various departments including Research and Development, Process Development, Quality and Documentation and to meet internal customer needs
• Monitor and verify quality of lab’s work
• Maintain and ensure proper documentation of quality records
• Assist in the development of new testing processes and procedures
• Establish and maintain lab layouts as testing requirements evolve to allow functionality for multiple groups, while optimizing efficiency
• Implement initiatives ensuring the test lab and warehouse remains tidy and in a state of readiness for product testing
• Ensure all supplies required for testing are well stocked
• Ensure lab equipment is in calibration and write OOTs if equipment drops out of calibration
• Knowledge of current safety guidelines including the use and disposal of chemicals and hazardous items
• Perform experiments and feasibility tests on a variety of designs.
• Assist in the generation of documentation (e.g. datasheets, technical reports, PowerPoint presentations).
• Fabricate prototypes and build test samples and equipment, build and test early stage prototype devices.
• Conduct safety and performance testing per defined protocols.
• Execute challenging product fabrication and process development assignments associated with concept feasibility, establishment, verification, validation, and manufacturing transfer phases of design control.
• Perform troubleshooting of process or testing problems and suggest alternatives.
• Prioritize and complete research in a timely, reproducible manner independently and within teams.
• Able to scientifically discriminate, analyze and offer conclusions to difficult laboratory problems.

Benefits

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: Associate degree
• Number of Employees: 5,001-10,000 employees