Training and Development Specialist

Lisle, Illinois, United States expand job description ↓

Description

This is an opportunity to join a dynamic start-up that is poised to revolutionize the clinical practice for patients with advanced heart failure. Endotronix, a growing medtech company located in Lisle, IL just outside Chicago, is advancing the treatment of heart failure (HF) with proactive data-driven solutions that improve the quality of life for patients and clinicians. The company’s platform streamlines care for patients with chronic heart failure. It is comprised of an intuitive patient management system and a wireless, implantable sensor to manage HF patients’ pulmonary artery pressure, a leading indicator for early detection of worsening heart failure. The comprehensive solution overcomes inefficiencies in managing these complex patients and extends clinical care into the home.

  • Set up and manage companywide training system (on-site and remote employees)
  • Set up training curriculums by department
  • Liaise with all department management to determine training needs, establish training curriculums and assignments based upon work functions, and schedule training sessions
  • Set up training requirements for production vs preproduction
  • Set up training requirements for skills based and instructor-led
  • Create and conduct annual or semi-annual training on mandatory training procedures
  • Ensure new or modified training materials or practices are communicated to departments and/or individuals affected by these changes and ensure appropriate involvement and communication
  • Metrics of training completion by department
  • Develop and provide data on Training KPIs
  • Represent the site training systems during audits
  • Ownership and maintenance of electronic training management system, including testing and validation of the software
  • Develop and maintain training metrics and monitor the effectiveness of training on employees using individual and/or group performance results and identify areas for improvements
  • Collaborate with key stakeholders, developing content and delivery of Quality System requirements to new employees.
  • Ensure affected employees and management are fully knowledgeable of training program requirements, systems, and record keeping practices, and train those staff as needed
  • Ensure the most effective delivery platform (e.g. web based, on the job, classroom, self-study, etc.) is used to meet employee development and organizational needs
  • As a QA function, review and approve training documents to ensure quality, compliance and effectiveness. Provide guidance and instruction to others in determining training needs and developing training plans, training content, and measures of training effectiveness
  • Effectively work with Subject Matter Expert to manage and deliver internal training
  • Coordinate and schedule training events
  • Maintain training records required by QA. Files include but are not limited to:
  1. Training requirements
  2. Training plans
  3. Training materials
  4. Training assessments
  5. Attendance and completion records
  6. Certificates and other required supporting documentation


Requirements

  • Bachelor’s Degree in a related field preferred, or equivalent education/experience
  • 2-3 years of related quality and training experience
  • Fundamental knowledge of training techniques, materials and adult learning
  • Proficient in MS Word, Excel and MS PowerPoint
  • Excellent communication, prioritization and organizational skills
  • Ability to present to a large or small group, both onsite and remotely (worldwide)
  • Ability to solve problems with little or no supervision

PREFERRED:

  • Familiarity with compliance training especially in a medical device or regulated business
  • Working knowledge of FDA and ISO 13485 requirements preferred
  • Experience in legal requirements and records maintenance within a regulated industry
  • Prior teaching experience or education in technical, manufacturing, biotech or scientific field
  • Familiar with training software and systems used to define training requirements, deliver training, and host training records
  • Proficient in G Suite, Slack, Zoom

Must be willing and able to travel In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the U.S. and to complete the required verification document upon hire. Endotronix participates in E-Verify

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Bachelor’s Degree in a related field preferred, or equivalent education/experience
2-3 years of related quality and training experience
Fundamental knowledge of training techniques, materials and adult learning
Proficient in MS Word, Excel and MS PowerPoint
Excellent communication, prioritization and organizational skills
Ability to present to a large or small group, both onsite and remotely (worldwide)
Ability to solve problems with little or no supervision
Familiarity with compliance training especially in a medical device or regulated business
Working knowledge of FDA and ISO 13485 requirements preferred
Experience in legal requirements and records maintenance within a regulated industry
Prior teaching experience or education in technical, manufacturing, biotech or scientific field
Familiar with training software and systems used to define training requirements, deliver training, and host training records
Proficient in G Suite, Slack, Zoom