Manufacturing Engineer II

LSI SOLUTIONS, Inc.; New York (NY); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Bonus Plan

401(k) Plan

Tuition Assistance

Employee Assistance Program

Product Discounts

Paid Holidays

PTO & Sick Time

Medical/Dental/Vision

Job summary

LSI SOLUTIONS®, located in Victor, NY, seeks a Manufacturing Engineer II to develop and improve manufacturing processes and production equipment. The role focuses on reducing waste, boosting productivity, and elevating product quality in a regulated medical device environment.

The ideal candidate will apply Lean, Six Sigma, and design-for-manufacturing principles, perform validations, and collaborate across functions to sustain regulatory compliance and on-time production.

Qualifications

• BS Engineering or Engineering Technology degree.
• 2–5 years of relevant experience in manufacturing engineering.
• Experience in medical device or pharma preferred.

Responsibilities

• Develop manufacturing processes meeting internal and external requirements.
• Specify, purchase, implement, and support new equipment.
• Create Process Control Plans.
• Provide technical support to production teams to resolve issues.
• Identify opportunities for continuous improvement.
• Contribute to process risk analysis activities.
• Ensure validation and MSA for test equipment.
• Update equipment specifications and documentation.
• Support fixture and tool development for production needs.
• Ensure compliance with safety regulations and ISO/medical standards.

Skills

Lean methodology

Six Sigma

5S

Value Stream mapping

Takt time

Design for Manufacturing

FMEA

Production readiness

Cell layout

3D CAD

GD&T

Problem solving

FDA QSR

ISO 13485

Statistical analysis

Education

BS Engineering or Engineering Technology

Tools

3D CAD software

Engineering software

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Manufacturing Engineer II

Full Time Victor, NY, Victor, NY, US

4 days ago Requisition ID: 2665

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: Manufacturing Engineer II

SHIFT HOURS: 8:00am to 5:00pm (days)

LOCATION: Onsite at LSI Solutions in Victor, NY

SALARY PAY RANGE: $80,000yr to $110,000yr

JOB SUMMARY

The Manufacturing Engineer is responsible for developing and improving manufacturing processes. They design and refine production equipment and processes to improve capability, enhance productivity, reduce waste, reduce risk, and elevate overall product quality. Manufacturing Engineers introduce new technologies, perform root cause analysis, implement corrective actions, and leverage problem solving skills and equipment expertise to support ongoing production.

ESSENTIAL FUNCTIONS

• 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.

ADDITIONAL RESPONSIBILITIES

• 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.

EDUCATION & EXPERIENCE

• 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.
• Experience in Medical Device or Pharma preferred.

KNOWLEDGE, SKILLS & ABILITIES

Level II

• 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.

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.
• Routine use of standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines.
• Regularly required to talk and/or hear.
• Extended cleanroom habitation, approximately 80% of shift time inside clean room and 20% in office.
• Bonus Plan, 401(k) plan with company match, Tuition Assistance, Employee Assistance Program (EAP) and Product Discounts
• 15 Paid Holidays, PTO, Sick Time
• Medical, Dental, Vision effective first day of employment

LSI SOLUTIONS® is an equal opportunity employer and does not discriminate based on any legally protected status or characteristic.

Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran.