LSI SOLUTIONS® founded in 1986, located in beautiful Victor, New York, is a dynamic and growing medical device company with over 500 employees dedicated to advancing minimally invasive surgical instruments through research, development, manufacturing, and marketing. We have doubled in size in just the last 4 years! The LSI Campus includes 10 buildings (170,000+ sq ft) on 95 meticulously cared for acres.

We are searching for passionate people looking to make a difference in the medical device industry. By joining LSI SOLUTIONS® an ISO 13485 certified company, you will become part of as energetic team working together to relentlessly pursue better patient outcomes with state-of-the-art devices. After all, our customer is ultimately the patient.

POSITION TITLE: CAPA Project Engineer I/II Days (8am to 5pm)

LOCATION: Onsite at LSI Solutions in Victor, NY

SALARY RANGE: $72,000 - $97,000

JOB SUMMARY: The CAPA Project Engineer combines elements of process and project engineering. Leads the corrective and preventive action (CAPA) process to ensure accurate root causes are determined, appropriate solution plans identified, and necessary product and process improvements are followed through effectively. This includes driving and motivating others to take action by engaging resources and leading small cross functional teams, and interfacing with management and peers to report progress and assess and improve the CAPA process.

ESSENTIAL FUNCTIONS:

Level I

• Maintain and administer individual Corrective Action Preventive Actions (CAPAs) within the electronic system.

• Directly facilitate and/or execute approximately 3 active CAPA projects, including but not limited to problem statement development, root cause investigation, corrective action development, and implementation.

• Monitor and support progress of additional CAPA projects being conducted by department specific teams.

• Devise accurate and appropriate methods for verifying effectiveness of implemented actions.

• Provide support to users of the CAPA system, including investigators, board members, and implementors.

• Employ common root cause techniques in the resolution of CAPAs.

• Revision to or writing of procedures and processing through change control with direction.

  Level II and Senior also responsible for

• Directly facilitate and/or execute approximately 5 active CAPA projects through implementation.

• Plan and lead routine CAPA review meetings.

• Maintain, monitor, and present metrics about the CAPA system to management.

• Employ specialized root cause techniques in the resolution of CAPAs.

• Develop, write, and revise CAPA Quality Management System (QMS) documentation, ensuring that process linkages are correctly documented throughout the QMS.

• Mentor more junior CAPA Engineers.

• Identification and implementation of improvements to the CAPA System.

• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving issues.

  ADDITIONAL RESPONSIBILITIES :

• Provide support for projects as needed.

• Provide support for internal and external audits and inspections as needed.

• All other duties as assigned.

  EDUCATION & EXPERIENCE:

  Level I

• Bachelor’s degree in Engineering, Business or relevant field.

• 0-3 years of relevant work experience.

  Level II

• Bachelor’s degree in Engineering, Business, or relevant field.

• 4+ years of relevant work experience, or Master’s degree with 3+ years of experience.

• Demonstrated experience leading problem-solving efforts required, CAPA system experience preferred.

• Experience in a regulated industry (e.g. Medical Device or Pharma) preferred.

  Senior

• Bachelor’s degree in Engineering, Business, or relevant field.

• 10+ years of relevant work experience, or Master’s degree with 8+ years of experience.

• Demonstrated experience leading problem-solving efforts required, CAPA system experience required.

• Experience in a regulated industry (e.g. Medical Device or Pharma) required.

  Completion of a relevant degree not listed above may be considered with additional applicable experience.

  KNOWLEDGE, SKILLS & ABILITIES:

  Level I

• Proficient with MS Office (Outlook, Word, Excel, PowerPoint).

• Mechanical aptitude and understanding of mechanical systems.

• Experience with 3D modeling or CAD to retrieve design information.

• Proficient technical writing skill to compose reports and documents for release within the QMS.

• Excellent communication skills (verbal and presentation).

• Experience with some necessary root cause analysis tools (e.g., 5 Whys, Fishbone, etc.)

• Experience with basic Lean concepts and tools (e.g., Kaizen, Value Stream Mapping).

• Ability to facilitate a small team.

  Level II

• Proficiency with all Level I Knowledge, Skills & Abilities.

• Proficient with all necessary root cause analysis tools (e.g., Fault Tree Analysis, Convergent Problem Solving, etc.)

• Solid organizational and planning skills and ability to work independently.

• Customer-focused, goal-oriented self-starter.

• Ability to manage multiple simultaneous tasks and projects.

  Senior

• Expert with all Level I & II Knowledge, Skills & Abilities.

• Ability to train employees at multiple levels of an organization.

• Must be effective in following-up and prompting others to take action.

• Ability to mentor Level I & II CAPA Engineers and team members on best practices and methodology.

  PHYSICAL DEMANDS AND WORK ENVIRONMENT:

  The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Regularly required to sit; use hands to handle or feel and talk or hear.

• Frequently required to reach with hands and arms.

• Occasionally required to stand; walk and stoop, kneel, crouch.

• Occasionally lift and/or move up to 10 – 20 pounds.

• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

  LSI SOLUTIONS® is an equal opportunity employer and does not discriminate based on any legally protected status or characteristic.

  Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran.