Manufacturing Engineer

LSI Solutions Inc•Victor, NY

11h•$64,500 - $137,500•Onsite

About The Position

LSI SOLUTIONS®, founded in 1986 and located in Victor, New York, is a growing medical device company with over 500 employees. We specialize in advancing minimally invasive surgical instruments through research, development, manufacturing, and marketing. We are an ISO 13485 certified company seeking passionate individuals to join our energetic team and contribute to better patient outcomes with state-of-the-art devices. The Manufacturing Engineer is responsible for developing and improving manufacturing processes. This includes designing and refining production equipment and processes to enhance capability, productivity, and product quality while reducing waste and risk. The role involves introducing new technologies, performing root cause analysis, implementing corrective actions, and leveraging problem-solving skills and equipment expertise to support ongoing production.

Requirements

BS Engineering or Engineering Technology.
Proficient in MS Office (Word, Excel, PowerPoint), Minitab or any other SPC software.
Capable of written and verbal presentation of technical concepts to leadership (Intermediate Proficiency).
Mechanical knowledge and aptitude to analyze and trouble shoot abnormal operation conditions on equipment, devices, fixtures, among others.
Familiar with manufacturing efficiency strategies such as Lean, Six Sigma, 5S, Value Stream mapping, etc.
Strong problem solving and analytical skills.
Knowledge in Design of Experiments and statistical analysis tools, and statistical process control.
Familiar with Design for Manufacturing, FMEA, Production Readiness, and Cell Layout.
Understanding of ergonomics as related to repetitive stress injuries.
Intermediate Writing skills to compose reports and documents for efficient information transfer.
Familiar with 3D CAD Design Software.
Problem solving and decision-making skills.
Ability to work independently and with a team.
Attention to detail.
Create Project Plans and organize resources to ensure project milestones are met within expectations of timeline and product quality.
Familiarity with working from ISO to other internationally recognized standards.
Familiarity in GD&T.
Knowledge of root cause analysis and problem-solving techniques.
Knowledge of Engineering and Manufacturing best practices.
Proficient with manufacturing efficiency strategies such as Lean, Six Sigma, 5S, Value Stream mapping, Takt time and its drivers and support tools, among others.
Proficient at Design for Manufacturing, FMEA, Production Readiness, and Cell Layout.
Expert writing skills to compose reports and documents for efficient information transfer.
Expert PC skills with Engineering and office related software systems.
Experience using 3D CAD Design Software.
Proficient in Problem solving and decision-making skills.
Knowledge and understanding of FDA QSR and ISO 13485, 14971.
Proficient with Design of Experimentation methodology and statistical analysis tools.
Work independently - self-motivated.
Proficiency in GD&T.
Excellent Organization, time management, and project management skills.
Expertise in problem solving and decision-making skills are necessary and ability to work independently and with a team.
Expertise with Creating Project Plans and organizes resources to ensure project milestones are met within expectations of timeline, quality, and budget.
Mentor/Train less experienced personnel on manufacturing Engineering methodology.

Nice To Haves

Experience in Medical Device or Pharma preferred.
MS with 1 to 5 years of experience within a regulated industry.
3-5 or more years of Engineering experience in medical device or other regulated industry acceptable with Master’s Degree.
5-7 or more years of Engineering experience in medical device or other regulated industry acceptable with Master’s Degree.
Experience in Medical Device or Pharma required.

Responsibilities

Develop manufacturing processes that can meet all internal and external requirements.
Specify, purchase, implement, and provide ongoing support for new manufacturing equipment.
Create Process Control Plans.
Provide technical expertise and troubleshooting assistance to production teams to resolve manufacturing issues, minimize downtime, and ensure smooth operations.
Identify and act upon opportunities for continuous improvement to manufacturing.
Contribute, as core team members, to process risk analysis activities.
Ensure continuous adequacy of test equipment and test methods through proper validation, measurement systems analysis, and Gage Repeatability and Reproducibility testing.
Write process deviation and rework instructions, as required.
Create and maintain accurate and up-to-date equipment specifications and other manufacturing processes documentation.
Support fixture and tool development to ensure that the needs of production are reflected in designs and specifications.
Provide technical support and expertise for manufacturing equipment validation activities.
Ensure compliance with safety regulations, industry standards, and good practices/ergonomics.
Manage multiple projects simultaneously.
Maintain accurate and compliant documentation to meet company and regulatory expectations.
Provide direction and help prioritize Technician tasks.
Accomplish all other duties and tasks as appropriately assigned or requested.