Manufacturing Engineer

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 I, II, III, or Senior (depending on experience)

SHIFT HOURS: Monday - Friday 8:00am - 5:00pm

REPORTS TO: Executive Director of Engineering, Principal Engineer

LOCATION: Onsite at LSI Solutions in Victor, NY

SALARY: 

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:

Manufacturing Engineer:

• 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:

Level I

• BS Engineering or Engineering Technology. 
• 0-2 years of relevant work experience in Manufacturing Engineering within a regulated industry.
• Experience in Medical Device or Pharma preferred.

Level II

• 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.

Level III

• BS Engineering or Engineering Technology. 
• 5 to 7 years of relevant work experience in Manufacturing Engineering or MS with 1 to 5 years of experience within a regulated industry.
• 3-5 or more years of Engineering experience in medical device or other regulated industry acceptable with Master’s Degree.
• Experience in Medical Device or Pharma preferred.

Senior

• BS Engineering or Engineering Technology. 
• 7-12 years of relevant work experience or MS with 6+ years of experience in Manufacturing Engineering within a regulated industry.
• 5-7 or more years of Engineering experience in medical device or other regulated industry acceptable with Master’s Degree.
• Experience in Medical Device or Pharma required.

KNOWLEDGE, SKILLS & ABILITIES:

Level I

• Proficient in MS Office (Word, Excel, PowerPoint), Minitab or any other SPC software.
• Capable of written and verbal presentation of technical concepts to leadership (Intermediate Proficiency).
• Mechanical knowledge and aptitude to analyze and trouble shoot abnormal operation conditions on equipment, devices, fixtures, among others.
• Familiar with manufacturing efficiency strategies such as Lean, Six Sigma, 5S, Value Stream mapping, etc. Strong problem solving and analytical skills.
• Knowledge in Design of Experiments and statistical analysis tools, and statistical process control.
• Familiar with Design for Manufacturing, FMEA, Production Readiness, and Cell Layout.
• Understanding of ergonomics as related to repetitive stress injuries.
• Intermediate Writing skills to compose reports and documents for efficient information transfer.
• Familiar with 3D CAD Design Software.
• Problem solving and decision-making skills. 
• Ability to work independently and with a team.
• Attention to detail.
• Create Project Plans and organize resources to ensure project milestones are met within expectations of timeline and product quality.
• Familiarity with working from ISO to other internationally recognized standards.
• Familiarity in GD&T.
• Knowledge of root cause analysis and problem-solving techniques.
• Knowledge of Engineering and Manufacturing best practices.

Level II, III

• 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.

Senior

• Expertise in problem solving and decision-making skills are necessary and ability to work independently and with a team.
• Expertise with Creating Project Plans and organizes resources to ensure project milestones are met within expectations of timeline, quality, and budget.
• Mentor/Train less experienced personnel on manufacturing Engineering methodology.
• All knowledge, skills, and abilities as listed for levels I, II, and III. 

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.

LSI SOLUTIONS® 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, 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.