What are the responsibilities and job description for the Equipment Engineer I position at Imperative Care?
Title: Equipment Engineer I
This position is based in our Campbell, California offices. This position is on-site, full-time.
Why Imperative Care?
Do you want to make a real impact on patients?
As part of our team at Imperative Care, you can help elevate care for patients suffering from stroke and other devastating vascular diseases. Every day, the technologies that we develop at Imperative Care directly impact people at the most vulnerable moments of their lives. Our focus is on the needs of the patient, and they come first in everything we do.
What You’ll Do
The individual in this position will utilizing their in-depth knowledge of mechanical, electrical and pneumatic systems to provide expert support of highly complex equipment used in the manufacturing of medical devices. This hands-on engineering position will resolve issues related to calibration, preventive maintenance, and repairs to manufacturing systems. This equipment engineering position requires the individual to draft installation/operation qualifications as well as design studies to determine equipment capabilities. In addition, the individual in this position will be required to address equipment related nonconformances and lead corrective and preventive actions. The Equipment Engineer must be flexible and adaptive and possess the ability to balance workload priorities and meet time-sensitive deliverables.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned on an individual basis:
- Assist with the verification of equipment calibration and preventive maintenance activities using Blue Mountain Regulatory Asset Manager (RAM) software.
- Assist with Ensuring that all equipment is installed, qualified, validated, and maintained in compliance with the company Quality System and regulatory requirements.
- Technical writing and composing of the following documents: equipment requirement specifications, equipment installation and operation qualification protocols, equipment calibration, maintenance procedures and standard operating procedures.
- Assess the efficiency of current procedures and identify areas of improvement to drive efficiency.
- Optimize and oversee calibration and maintenance methods and strategies to maintain the safe and reliable operation and uptime of equipment.
- Address equipment related nonconformances. Draft NCRs and be the point person to lead equipment related corrective and preventive actions (CAPAs).
- Work with cross functional peers to develop and implement comprehensive timelines and project plans. Partner with R&D, Process Development, and Manufacturing Engineering to ensure proper design and selection of equipment.
- Support continuous improvement through design, process development, and manufacturing strategies.
What You’ll Bring – minimum requirements for this role:
- Bachelor/Master ’s in Engineering or related discipline and less than 2 years of related experience; or equivalent combination of education and work experience in the medical device or related regulated industry
- Knowledge or experience within an FDA and ISO 13485 regulated environment using GDP and GMP practices.
- Some previous equipment maintenance experience preferred. Must be able to read and interpret manuals, assembly drawings, electrical and system schematics.
- Must have a strong working knowledge in mechanical alignment and troubleshooting complex electromechanical systems, pneumatic systems, electrical/electronic components, optics, sensors, optics, motors, and PLCs.
- Strong critical thinking – able to intuitively identify problems, logically and empirically associate cause and effect, and under a variety of perspectives and constraints, prioritize and provide creative, effective and practical solutions. Experienced with troubleshoot problems and assess whether equipment and/or parts can be repaired or need to be replaced. Order and install replacement equipment and/or parts.
- Experience with designing equipment and fixtures using CAD/SolidWorks. Reviewing and creating detailed prints.
- Analytical and statistical skills (SPC) using Excel, Minitab and/or JMP.
- Knowledge or experience within an FDA and ISO 13485 regulated environment using GDP and GMP practices.
Join Us! Imperative Care
Salary Range: $84,000 – 89,000 annually
Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position, candidate's work experience, education/training, key skills, and internal equity, as well as location, market and business considerations when extending an offer. As part of our total rewards package, Imperative Care offers comprehensive benefits including a 401k plan, health benefits, generous PTO, a parental leave program and emotional health resources.
Salary : $84,000 - $89,000
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