Packaging Engineer 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

Packaging Engineer III or Sr.

SHIFT HOURS

8:00am to 5:00pm .

LOCATION

Onsite at LSI Solutions in Victor, NY .

SALARY RANGE

$92,000 to $110,000 .

JOB SUMMARY

The Packaging Engineer will design, test, and implement new & existing packaging designs to meet medical device product requirements. In addition, the Packaging Engineer will support Quality with sterility assurance program including planning & executing required sterilization validation, and revalidation of new and existing product development activities in accordance with internationally recognized sterilization standards.

ESSENTIAL FUNCTIONS

+ Reviews product engineering change orders and packaging process changes, including labels specifications, and packaging related content. + Participate in vendor reviews for development of packaging for components and materials. + Draft protocols and reports for packaging testing & validations, including packaging integrity, seal strength, shelf-life studies & accelerated aging, transportation, and distribution testing. + Ensures that project and process development documentation are compliant with requirements and objectives. Reviews designs, changes specifications, and plans against process requirements. + Contribute to development of packaging designs, including prototyping of packaging concepts. + Supports Corrective and Preventive Actions (CAPA) processes and root cause investigations. + Supports Design and Process FMEAs to develop robust packaging systems and processes. Packaging Engineer III + All essential functions listed above. + Lead the development of packaging designs, including prototyping of packaging concepts. + Establish equipment requirements, selection, and modifications for new and improved packaging processes to meet packaging processing and technology changes. + Identify and optimize packaging process alternatives to improve quality, yield, cycle time, and cost. + Communicate with vendors with support from Supply Chain team. + Provides direction for equipment qualifications (IQ, OQ, PQ) on new/existing processes & equipment. + Support Sterility Assurance program including planning and execution of required sterilization validation work in support of manufacturing and new product development activities in accordance with internationally recognized sterilization standards. + Supports Design and Process FMEAs to develop robust packaging systems and processes. + Represent Packaging Engineering during internal & external audits. Senior Packaging Engineer + All essential functions listed above. + Lead and manage complete packaging development process, including the creation of packaging designs, prototype development, performance testing and implementation. + Lead Design and Process FMEAs to develop robust packaging systems and processes. + Use Packaging DFMEAs to determine qualification requirements & pass/fail criteria for in-process test. + Continually analyze environmental and/or utility monitoring data from the manufacturing areas for purposes of remediation of any developing trends. + Provide functional mechanical expertise, leadership, and mentorship to technicians & team members. + Understand and communicate regulatory implications related to Internal Customers. + Advanced knowledge and apply engineering mechanical principles, analytical techniques, and judgement to independently resolve major technical issues. + Strong understanding of LSI product lines.

ADDITIONAL RESPONSIBILITIES

+ Provide technical support to all engineering and manufacturing. + Supports manufacturing issues, CAPA’s, SCARS and audits. + Maintains accurate and compliant documentation to meet Company and regulatory expectations. + Stay current with controls technology advancements & bring innovations to improve the current designs. + Support data systems integration in production areas. + Coordination with appropriate supporting departments to ensure OSHA compliance and overall employee safety surrounding existing and proposed installations. + Develop procedures, standards, and instructions to support installations (lockout – tagout, preventive maintenance, etc.). All other duties as assigned.

EDUCATION & EXPERIENCE

+ BS Packaging Science or related technical field required. + Knowledge of medical device technologies preferred. + Knowledge of clean room practices preferred. Packaging Engineer III + 5+ years of relevant work experience as Packaging Engineer. + 3+ years of relevant engineering experience in medical device or other regulated industry. + Experience with

EN ISO 11135

Medical devices – Validation and routine control of ethylene oxide sterilization, ISO 11607 Packaging for terminally sterilized medical devices, EN

ISO 10993 FDA QSR/21 CFR

Part 820, ISO 14971 and

ISO 13485

required. + Experience developing high & low volume manufacturing equipment. Senior Packaging Engineer + 8+ years of relevant work experience. + 5+ years of relevant engineering experience in medical device or other regulated industry. + Demonstrated experience with

EN ISO 11135

Medical devices – Validation and routine control of ethylene oxide sterilization, ISO 11607 Packaging for terminally sterilized medical devices, EN

ISO 10993 FDA QSR/21 CFR

Part 820, ISO 14971 and

ISO 13485

required. + Experience leading high & low volume manufacturing equipment development. + Demonstrated experience creating project plans and organizing resources to ensure project milestones are met within expectations of timeline, quality, and budget.

KNOWLEDGE, SKILLS & ABILITIES

Knowledge of Design for Manufacturing, FMEA, and Packaging Design Validations. + Experience with

ISO 11607, ASTM

D6198 and

ASTM D4169.

+ Experience with ASTM and ISTA package test methods. + Experience using 3D CAD Design Software (i.e. Inventor or SolidWorks). + Experienced executing Problem solving and decision-making skills. + Experience with written and verbal presentation of technical concepts. + Experienced in Design for Manufacturing, FMEA, and Packaging Design Validations. Packaging Engineer III + Experienced leading Problem solving and decision-making skills. + Led Design for Manufacturing and Packaging Design Validations. + Led problem solving events including Process Excellence tools – ex. FMEA, Cause & Effect, DOEs, etc. + Able to run packaging prototyping equipment (ex. cutting tables and thermoforming). + Demonstrated use of Project Management Skills for large projects. + Experienced leading a cross-functional team. Senior Packaging Engineer + All above-listed Knowledge, Skills & Abilities at a Proficient Level. + Strong delivery of written and verbal presentation of technical concepts. + Excellent verbal & written communication skills, including presenting to Leadership. + Knowledge of EtO terminal sterilization processing experience in the medical device required. + Demonstrate example leading full projects – creating project plans and organizing 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 bend or kneel and use color vision/depth perception. + Sitting, standing and/or walking for up to eight hours per day. + Routine use of standard office equipment such as computers, phones, and photocopiers. + 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