Alignment Technician (Medical Device)
The Alignment Technician I, will be responsible for:
· Integration, test, calibration, alignment, and troubleshooting of high complexity optical, fluidic, electronic, and mechanical instruments.
· Includes working directly with Class III lasers
· Delivering manufacturing requirements to production schedules within a focused manufacturing operation. Work schedule may include alternate shifts
· Production scope includes new instrument builds, field service sub-systems, and return repairs
What you will do
- Execute manufacturing requirements in accordance with production schedule.
- Adhere to documented procedures and maintain quality data.
- Deliver timely and accurate completion of manufacturing sections of process documentation and related business system transactions.
- Document non-conformances.
- Troubleshoot and re-work in coordination with extended team members and engineering support.
- Participate in the design transfer and integration of new products and processes.
- Conduct task specific training and provide technical guidance
- Maintain current and effective training to standard operating procedures, work instructions, and applicable changes affecting Instrument Manufacturing.
- Maintain cleanliness and integrity of work cell and related manufacturing area.
- Performs timely and accurate inventory cycle counts of floor inventory.
- Monitor select non-inventory supplies, maintain focused supplies, and generate purchase requisitions as needed.
- Participate investigations and resolution of findings impacting the Instrument Manufacturing Organization identified through audits, non-conformances, corrective/preventive actions, customer complaint escalations, and field service feedback.
- Collaborate with manufacturing engineering resources for work instruction and standard operating procedure updates.
- Maintain personal compliance and facilitate departmental compliance with the Quality System.
- Adhere to safety, disposal, and gowning requirements.
- Assist in task-specific engineering change training, Oversee the training of new Manufacturing Associates
- Other duties as assigned.
- H.S. Diploma required
- Associate's Degree preferred
- 1+ Years Alignment on the job experience required
- 2+ Years Alignment on the job experience preferred
Training and Skills
- Understanding of calibration (High proficiency)
- Ability to read and understand electrical, mechanical and hydraulic schematic diagrams. (High proficiency)
- Familiarity with ISO 13485 and FDA Quality System requirements desired. (Medium proficiency)
- Familiarity with Enterprise Manufacturing systems such as Oracle or SAP desired. (Medium proficiency)
- Strong optical, electrical, and mechanical aptitude. (Medium proficiency)
- Proficiency in laser safety (Medium proficiency)
- Well-developed problem solving/troubleshooting skills. (Medium proficiency)
- Proficiency using standard test equipment such as oscilloscopes, DMM’s, signal generators, power meters, and AC/DC power supplies (Medium proficiency)
- Proficiency with Microsoft Word and Excel. (Medium proficiency)
- Effective oral and written communication skills. (Medium proficiency)
Licenses and Certifications
- Electronics Certification-ETA preferred