Manufacturing Engineer II

LSI Solutions Inc•Victor, NY

25d•$80,000 - $110,000•Onsite

About The Position

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.

Requirements

BS Engineering or Engineering Technology.
2 to 5 years of relevant work experience in Manufacturing Engineering or MS with 1 to 5 years of experience within a regulated industry.
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.
All knowledge, skills, and abilities as listed for level I.

Nice To Haves

Experience in Medical Device or Pharma preferred.

Responsibilities

Develop manufacturing processes that can meet all internal and external requirements.
Specify, purchase, implement, and provide ongoing support for new manufacturing equipment.
Responsible for creating Process Control Plans.
Provide technical expertise and troubleshooting assistance to production teams to resolve manufacturing issues, minimize downtime, and ensure smooth operations. This may involve analyzing data, conducting experiments, and collaborating with cross-functional teams to address problems and optimize production output.
Identify and act upon opportunities for continuous improvement to manufacturing.
Contribute, as core team members, to process risk analysis activities.
Responsible for ensuring 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.
Must be able to manage multiple projects simultaneously.
Maintains accurate and compliant documentation to meet company, and regulatory expectations.
Provides direction and helps prioritize Technician tasks.
Accomplishes all other duties and tasks as appropriately assigned or requested.