Production Engineer I, II, III or Sr. (Days 8am to 5pm)

LSI Solutions Inc•Victor, NY

5d•$85,000 - $120,000•Onsite

About The Position

LSI SOLUTIONS®, a growing medical device company, is seeking passionate individuals to join their team. As an ISO 13485 certified company, LSI SOLUTIONS® is dedicated to advancing minimally invasive surgical instruments. The Production Engineer will be responsible for manufacturing process development, production transfer, product and problem diagnosis and repair, as well as the development, qualification, verification, and validation of manufacturing processes. The role requires strong problem-solving and analytical skills, knowledge in Design of Experiments (DOE) and statistical process control, and the ability to maximize efficiency by analyzing equipment layouts, workflow, assembly methods, and workforce utilization.

Requirements

Production Engineer I, II, III: B.S. Degree in mechanical, manufacturing, industrial engineering or similar technical field or 2-year technical degree with 4 to 7 years of relevant manufacturing experience.
Senior Production Engineer: B.S. Degree, with a minimum 8+ years’ work experience in Manufacturing Engineering with 4 + experience in the medical device or pharmaceutical industry (or similar highly regulated field).
Familiar with manufacturing efficiency strategies such as Lean, Six Sigma, 5S, Value Stream mapping, etc.
Experience in Design for Manufacturing, FMEA, DOE, and Validations.
Understanding of ergonomics as related to repetitive stress injuries.
Problem solving and decision-making skills are necessary.
Ability to work independently and with a team including working knowledge of Problem – Issue – Opportunity board or similar issue tracking/containment tool.
Attention to detail and tasks being performed in order to identify potential changes and/or problems with the processes and products.
Creates Project Plans and organizes resources to ensure project milestones are met within expectations of timeline, quality, and budget.

Nice To Haves

Experience in a medical device/pharmaceutical manufacturing (or similar highly regulated industry) preferred.
Experience using 3D CAD Design Software preferred

Responsibilities

Provide technical support working closely with Team Leaders, Supervisors, and fellow Engineers.
Ensure efficient operation of manufacturing processes within production; create project plans, perform utilization studies, identify capacity needs and constraints, and make recommendations for improvements.
Lead in the selection, installation, and validation of medical device process/packaging equipment utilizing project management tools, Risk Analysis/pFMEA, and Lean Manufacturing techniques.
Assist in Preventive Maintenance (PM) procedures and executing PMs for cleanroom equipment and production equipment associated with packaging or production activities.
Assist in writing and executing process qualification protocols and reports, understanding of IQ, OQ, and PQ.
Define, communicate, and develop fixture concepts using internal and external resources, incorporating the capabilities of typical production association into these concepts.
Prepare product and process reports by collecting, analyzing, and summarizing information and trends.
Review of component designs and identification of Design for Manufacturing and Assembly (DFMA) opportunities.
Identify critical component functions and determine which manufacturing techniques will provide the optimal outcome.
Responsible for proper installation of new equipment and setting up proper preventive maintenance and calibration plans.
Develop detailed process qualification strategies.
Define statistical sample sizes as related to variable and attribute data, based on established company and industry standards.
Advanced experience in Design of Experimentation methodology and statistical analysis tools.
Review of proposed component tolerances and input to manufacturing capability.
Understands GD&T and how to properly apply it to yield the desired fits between joining parts.
Responsible for developing detailed Process FMEAs and using the output to develop robust manufacturing processes.
Use FMEA output to determine in-process testing and product final inspection requirements.
Manage multiple projects simultaneously.
Support alternative shifts, as needed.
Maintain accurate and compliant documentation to meet company and regulatory expectations.
Provide direction and help prioritize Production Technician tasks.
Accomplish all other duties and tasks as appropriately assigned or requested.