LSI SOLUTIONS® founded in 1986, located in beautiful Victor, New York, is a dynamic and growing medical device company with over 450 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 7 buildings (165.000 sq ft) on 60 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 ultimate customer is the patient.

Position Title: Manufacturing / Operations Engineer - (Evenings 2pm to 11pm)

JOB SUMMARY: The Operations Engineer provides support to Cleanroom Assembly Area, with a focus on process improvement, cycle time reduction, waste elimination and defect prevention. Individual will be required to participate in process improvement initiatives, establishment of process base line metrics such as OEE, and SPC implementation and process data analysis.

ESSENTIAL FUNCTIONS:

Operations Engineer I:

• Provide daily on-the-floor technical support working closely with Manufacturing Cell Leads, Supervisors, Production Technicians, Maintenance Technicians, and Quality and Manufacturing Engineers. Ensures efficient operation of manufacturing processes within production; creates project plans, performs utilization studies, identifies capacity needs and constraints, and makes improvements.
• Provides information by collecting, analyzing, and summarizing product and process variation trends.
• Troubleshoot and remediate problems with existing production processes to ensure throughput.
• Support the selection, installation, and validation of medical device process/packaging equipment utilizing project management tools, Risk Analysis/pFMEA, and Lean Manufacturing techniques.
• Understanding and calculating process capability (OEE, OOE, TEEP, FPY, etc.).
• Prepares product and process reports by collecting, analyzing, and summarizing information and trends.
• Responsible to support proper installation of new equipment.
• Responsible for supporting the process qualification protocols and reports (IQ, OQ, and PQ).
• Support the operational excellence design, deployment, execution, and continuous improvement.
• Provide daily Operational KPI's status on assigned manufacturing area/shift and lead a multidisciplinary team to provide the required corrective, preventive, improvement and risk mitigation actions.
• Evaluates and promote the adequacy of work instructions, visual aids and set up sheets.
• Evaluates and promote the adequacy and effectiveness of the standardized visual management system.
• Maintains safe and healthy work environment by following and enforcing standards and procedures and complying with legal regulations.
• Understands GD&T and is experienced on how to apply it.
• Conducting safety / ergonomic assessments.

Operations Engineer II:

• Anticipates operational problems by studying operating targets, and modes of operating variations.
• Monitors operations with an eye toward improving productivity and efficiency through Value Stream Maps, cycle times and optimum line balancing.
• Evaluates and promote the adequacy of existing PFD, PFMEA, and PCP/ MIP.
• 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.
• Understands GD&T and is experienced on how to apply it.

Senior Operations Engineer:

• 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.
• Lead the operational excellence design, deployment, execution, and continuous improvement.
• Use lean manufacturing tools to improve efficiency and quality of manufacturing operations.
• Review of proposed component tolerances and input to manufacturing capability. Understands GD&T and how to properly apply it.
• 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 manufacturing cells and improvement projects simultaneously.
• Maintains accurate and compliant documentation to meet company, and regulatory expectations.
• Provides direction and helps prioritize Production/Maintenance Technician tasks.
• Research, recommend, and act on personal and professional development opportunities for self and department.
• Research, develop, and implement necessary systems, competencies, and tools required to improve capability and capacity of the team.
• Responsible for the appropriate record keeping of project outputs in accordance with recognized domestic and international medical device regulations, LSI Procedures, and other applicable standards.
• Provide input on and support for capital equipment purchases including tools and software, hiring decisions, performance review and bonus considerations, employee morale & welfare, and corporate structure.
• Teach and instill departmental discipline in timely, data driven decision making.
• Manage and report on departmental projects via project Focus Maps.
• Maintain knowledge of current trends and regulations; recommend and follow through on continuous improvement & training initiatives.
• Research, recommend, and implement best-in-class engineering practices & methodologies.
• Identify staffing needs and adjust as needed per departmental performance standards and skills/knowledge matrices. Support recruiting efforts.
• Conduct departmental performance reviews; develop succession plans, personnel development and growth initiatives, work improvement plans, and disciplinary actions when warranted.
• Promote and demonstrate customer service mentality via inter-departmental relations and support.
• Ensure departmental and personnel on-time training compliance with Company policies and procedures.
• Serve as key safety advocate and policing authority; ensure team functions in a safe manner and is aware of safety rules & regulations.
• May need to work long hours when necessary to complete time sensitive projects.
• All other duties as assigned.

EDUCATION & EXPERIENCE:

Operations Engineer I & II:

• B.S. Degree in mechanical, manufacturing, engineering, or similar technical field
• 3+ years of relevant operations/manufacturing engineering experience in Automotive, Medical Device, Pharma, or equivalent highly regulated manufacturing industry.

Senior Operations Engineer:

• B.S. Degree in mechanical, manufacturing, engineering, or similar technical field
• 6+ years of relevant operations/manufacturing engineering experience in Automotive, Medical Device, Pharma, or equivalent highly regulated manufacturing industry.

KNOWLEDGE, SKILLS & ABILITIES:

• Excellent communication skills, including technical writing and delivery of executive-level presentations.
• Familiar with manufacturing efficiency tools such as Lean - Six Sigma, 6S, Value Stream mapping, SPC, Process capability, installed capacity, 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 and ability to work independently and with a team.
• Proven proficiency in MS Office (Power point, Excel, etc.) and statistical software such as Minitab.
• Attention to detail and tasks being performed in order to identify potential changes and/or problems with the processes and products.
• Creates Action Plans and organizes resources to meet timeline, quality, and budget.
• Experience using 3D CAD Design Software (desired).

• Excellent Organization, time management and project management skills.

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.

• Extended cleanroom habitation, approximately 90% of shift time inside clean room and 10% in office.

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.