Production Engineer I, II, III or Sr. (Days 8am to 5pm) Position Available In Ontario, New York

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.

POSITION TITLE

Production Engineer I, II, III or Sr. (Component and Assembly Support)

SHIFT HOURS

8:00am to 5:00pm .

LOCATION

Onsite at LSI Solutions in Victor, NY .

SALARY RANGE

$75,000 to $128,000

JOB SUMMARY:

The Production Engineer is responsible for manufacturing process development, production transfer, product and problem diagnosis and repair. Responsible for the development, qualification, verification and validation of manufacturing processes. Strong problem solving and analytical skills. Knowledge in Design of Experiments (DOE) and statistical process control. Maximizes efficiency by analyzing equipment layouts, workflow, assembly methods, and work force utilization.

ESSENTIAL FUNCTIONS

Production Engineer

I, II, III

+ 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.

Senior Production Engineer:

+ All responsibilities listed above. + 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.

ADDITIONAL RESPONSIBILITIES

+ 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.

EDUCATION & EXPERIENCE

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. + Experience in a medical device/pharmaceutical manufacturing (or similar highly regulated industry) preferred.

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).

KNOWLEDGE, SKILLS & ABILITIES

+ 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. + Experience using 3D CAD Design Software preferred + 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.

PHYSICAL DEMANDS AND WORK ENVIRONMENT

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. + Frequently required to lift, carry, push and/or pull from 30-50 lbs. + Ability to periodically climb and use color vision/depth perception. + Sitting, standing and/or walking for up to eight hours per day. + Frequently communicates with other departments who have inquiries about projects, packaging specifics and sterilization procedures. Must be able to exchange accurate information in these situations.

GENEROUS LSI BENEFITS INCLUDE

+ Bonus Plan, 401(k) plan with company match, Tuition Assistance, Employee Assistance Program (EAP) and Product Discounts + 15 Paid Holidays, PTO, Sick Time + Medical, Vision and Dental effective first day of employment + Employee Referral Bonuses

LSI SOLUTIONS

® is an equal opportunity employer and does not discriminate on the basis of any legally protected status or characteristic. Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran