LSI SOLUTIONS® · 2 months ago
Production Engineer I, II, III or Sr.
Victor, NY
Full-time
Onsite
Entry, Mid, Senior Level
$75K/yr - $128K/yr
2+ years expLSI SOLUTIONS® is a dynamic and growing medical device company located in Victor, New York, dedicated to advancing minimally invasive surgical instruments. The Production Engineer is responsible for manufacturing process development, production transfer, product and problem diagnosis and repair, and ensuring efficient operation of manufacturing processes within production.
Health CareManufacturingMedical
Responsibilities
Provide technical support working closely with Team Leaders, Supervisors, and fellow Engineers, as needed. Ensures efficient operation of manufacturing processes within production; creates project plans, performs utilization studies, identifies capacity needs and constraints, and makes 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, as needed
Assist in writing and executing process qualification protocols and reports, as needed. Understanding of IQ, OQ, and PQ
Able to define, communicate, and develop fixture concepts using internal and external resources. Able to incorporate the capabilities of typical production association into these concepts
Prepares 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. Able to 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
Responsible for developing detailed process qualification strategies. Able to define statistical sample sizes as related to variable and attribute data, based on established company and industry standards
Advanced experience 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. Also using the output to determine in-process testing and product final inspection requirements
Must be able to manage multiple projects simultaneously
Must be able to support alternative shifts, as needed
Maintains accurate and compliant documentation to meet company, and regulatory expectations
Provides direction and helps prioritize Production Technician tasks
Accomplishes all other duties and tasks as appropriately assigned or requested
Qualification
Required
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
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)
Strong problem solving and analytical skills
Knowledge in Design of Experiments (DOE) and statistical process control
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 and 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
Must be able to manage multiple projects simultaneously
Must be able to support alternative shifts, as needed
Maintains accurate and compliant documentation to meet company, and regulatory expectations
Provides direction and helps prioritize Production Technician tasks
Preferred
Experience in a medical device/pharmaceutical manufacturing (or similar highly regulated industry)
Experience using 3D CAD Design Software
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