LSI SOLUTIONS® · 2 months ago
CAPA Project Engineer II or Sr.
Victor, NY
Full-time
Onsite
Mid, Senior Level
$77K/yr - $110K/yr
4+ years expLSI SOLUTIONS®, a medical device company located in Victor, New York, is seeking a CAPA Project Engineer II or Sr. to lead the corrective and preventive action (CAPA) process, ensuring effective solutions and improvements are implemented. The role involves facilitating CAPA projects, mentoring junior engineers, and maintaining metrics to provide insights into the CAPA program health.
Health CareManufacturingMedical
Responsibilities
Directly facilitate and/or execute CAPA projects, including but not limited to problem statement development, root cause investigation, corrective action development, and implementation with minimal mentoring
Plan and lead routine CAPA review meetings
Maintain, monitor, and present metrics about the CAPA system to management
Employ specialized root cause identification techniques in the successful resolution of CAPAs (e.g. Fault Tree Analysis, Convergent Problem Solving, etc.)
Develop, write, and revise Quality Management System (QMS) documentation, ensuring that process linkages are correctly documented throughout the QMS
Assist in the identification and implementation of improvements to the CAPA System
Mentor more junior CAPA Engineers in CAPA process and guide the execution of CAPAs
Lead the identification and implementation of continuous improvement efforts of the CAPA process
Continuously develop and review metrics to provide management insight into CAPA program health
Provide support for projects as needed
Provide support for internal and external audits and inspections as needed
All other duties as assigned
Qualification
Required
Bachelor's degree in Engineering or relevant technical field
4-7 years of relevant work experience, or Master's degree with 3+ years of experience
Experience applying lean manufacturing principles and Six Sigma methodologies required
Demonstrated experience successfully leading problem-solving efforts required
CAPA system experience preferred
Experience in a regulated industry (e.g. Medical Device or Pharma) preferred
7+ years of relevant work experience, or Master's degree with 6+ years of experience
Experience successfully applying lean manufacturing principles and Six Sigma methodologies required
Certification in Six Sigma preferred
Demonstrated experience successfully leading problem-solving efforts required
CAPA system experience required
Experience in a regulated industry (e.g. Medical Device or Pharma) required
Experience successfully mentoring less experienced engineers
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)
Proficiency in manufacturing process design and optimization
Knowledge of lean manufacturing principles and Six Sigma methodologies
Ability to facilitate a small team
Ability to manage multiple simultaneous tasks and projects
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
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
Preferred
CAPA system experience preferred
Experience in a regulated industry (e.g. Medical Device or Pharma) preferred
Certification in Six Sigma preferred
Benefits
Bonus Plan
401(k) plan with company match
Tuition Assistance
Employee Assistance Program (EAP)
Product Discounts
15 Paid Holidays
PTO
Sick Time
Medical, Vision and Dental effective first day of employment
Employee Referral Bonuses
Company
LSI SOLUTIONS®
We at LSI Solutions integrate patient‑focused values, precision manufacturing, and deep surgical collaboration to redefine what's possible in minimally invasive surgery.
501-1000 employees
H1B Sponsorship
LSI SOLUTIONS® has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (4)
2023 (1)
2022 (1)
2021 (1)
Funding
Current Stage
Late StageLeadership Team
J
Jude S. Sauer
President & CEO
Recent News
2025-04-02
Company data provided by crunchbase