Manufacturing Engineer

Manufacturing Engineer

Location: EXALTA Group - Bonita Springs, FL
Reports To: Engineering Manager

Position Summary:

The Manufacturing Engineer applies advanced engineering principles, technical expertise, independent judgment, and analytical problem-solving to design, develop, validate, and continuously improve manufacturing processes for precision medical-device components. The position independently evaluates manufacturing requirements, develops technical solutions, leads process improvement and validation activities, and provides engineering guidance supporting product quality, manufacturability, cost, and operational performance.

Essential Duties and Responsibilities :

• Act as project manager and customer point of contact for projects and technical engineering information, ensuring customer satisfaction.
• Develop and implement - PFP's, PFMEA's & Control plans as needed.
• Perform reviews of customer orders and determine processing requirements to produce cost effective conforming components and assemblies.
• Develop manufacturing processes and routers that are consistent with customer (Quality agreement) and BMI operating procedures and work instructions through analysis of application, research, design, modification, and testing of manufacturing methods and equipment.
• Develop machine and secondary process validations and follow through to ensure completion of validations.
• Develop testing protocols working with R&D and the engineering team.
• Evaluate and improve manufacturing processes to support customer and BMI requirements by working closely with production; designing and conducting research; applying knowledge of product design, fabrication, assembly, tooling and materials.
• Use lean tools and principles to reduce various forms of waste in manufacturing processes to reduce product cost and lead time, while maintaining or improving quality.
• Develop prints, create BOMs and routings within the ERP system as needed.
• Review prints for proper instrument function, manufacturability and inspection.
• Participate to vendors' evaluation and engineering management of them.
• Assist ME's, QE's with a range of machine and process validation activities as needed (IQ,OQ,PQ).
• Participate in design review with RD team and customers, validation process and continuous improvement activities.
• Participate at vendors' audits with quality, to insure all BMI requirements are fully understood and applied.
• Manage the manufacturing processes for new orders from concept to production. Guarantor of processes within the company.
• Create a part number data base to reflect whether product is manufactured in-house or outside.
• Analyze manufacturing performance through time studies and other engineering methods and independently identify, develop, and implement continuous-improvement opportunities.
• Partner with the programming department to develop/design custom tooling that would be required for machining, or purchase tooling as required.
• Review subcontractor processes for efficiency and challenge the process when needed; participate in audits as needed.
• Provide engineering analysis and technical input to support quoting, including evaluation of manufacturing methods, process requirements, tooling, equipment, and technical feasibility.
• Process owner to improve Epicor utilization for the manufacturing engineers.
• Assist with material review board when there is non-conformance product.
• Identify and justify new equipment reflective of process improvements.
• Complaint handling support.
• Lead and support the CAPA and Complaint processes to ensure timely closure, for engineering, subcontracting or manufacturing subjects.
• Facilitate team meetings to actively manage the planning process for new projects.
• Serve as the engineering technical authority for manufacturing issues, independently analyzing complex production problems and developing appropriate engineering solutions.
• Assist with leading and developing the engineering team.
• All other duties as assigned.

Knowledge, Skills & Competencies:

• Minimum of 7 years of related experience in Manufacturing Engineering in a machining production and design facility.
• Proficient with project planning; ability to effectively manage multiple projects; proven experience in leading process improvement projects required.
• Experience in medical device manufacturing environment preferred.
• Strong experience with planning, developing and conducting tests to validate machine and secondary processes.
• Thorough understanding of raw materials, manufacturing processes, and quality control practices.
• Extensive knowledge of CNC machining, tooling, processes and machining capabilities.
• Advanced knowledge and understanding of blueprints and GD&T.
• Knowledge of Statistical Process Control (SPC) is a plus.
• Proficient in machine shop math.
• Experience in ISO 13485 /FDA 21 CFR820 preferred.
• Prior experience with CAPAs and complaints.
• Ability to understand the technical attributes of a wide range of precision, mechanical products.
• Strong root cause analysis skills and ability to identify complex problems and review related information to develop and evaluate options and implement solutions.
• Ability to communicate effectively in multi-discipline, cross cultural environment and levels of organization.
• Ability to work in a team environment, as well as, autonomously.
• Capable of handling stressful situations and manage conflict.
• Ability to read and comprehend complex instructions.
• Maintain sense of urgency and ability to prioritize work.
• Proficient in SolidWorks.
• Computer literate in various software applications (i.e. Microsoft Office).
• Experience leading a team of engineers.
• Strong understanding of Lean Manufacturing and or 6 Sigma.
• Strong customer service and communication skills with both internal and external customers.

Work Environment:

• The noise level in the work environment is usually moderate.
• Work environment consists of time spent in both an office (50%) and manufacturing environment (50%).
• Includes potential exposure to sounds and noise levels that can be distracting or uncomfortable.
• Includes potential exposure to moving mechanical parts.
• Includes potential exposure to coolants and oils.
• Work environment is temperature controlled.

The work environment described here is representative of that which an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Physical Job Requirements:

• While performing the duties of this job the employee is regularly required to sit, stand or walk; use hands, handle, or feel objects, tools or controls; reach with hands and arms; talk and hear.
• The employee must be able to lift and/or move up to 50 pounds.
• Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus.
• The employee must be able to sit or stand for up to 12 hours per day.
• Ability to function in highly stressful situations.

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 these essential functions.

Education, Certifications, and/or Licenses Requirements:

• Bachelor's degree in Engineering or a closely related engineering discipline required

Why Join EXALTA?

At EXALTA, we partner with leading medical technology companies to bring life-changing products to market. You will play a key role in building a culture of continuous improvement, enabling scalable growth, and helping deliver our mission: Together, we make MedTech better.

EXALTA is an Equal Opportunity Employer. We respect every employee as an individual, and we hire and promote based on qualifications, performance, and potential - without regard to race, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.