Director, Equipment and Automation

CORE RESPONSIBILITIES

• The ideal candidate will have experience developing custom PC and PLC based automated equipment including concept development, layout design, detailed component design, integration specification, control panel wiring, PLC/HMI programming, tool assembly build, start up and qualification.
• This position has responsibility and authority to:
• Establish and lead a team to design and build equipment for use in manufacturing and testing of surgical capital equipment, disposable instruments and accessories.
• Develop relationships with external automation and tooling suppliers to increase capacity to develop and deploy solutions.
• Establish standards for equipment design, performance, validation and maintenance.
• Develop and execute equipment/automation strategy in support of overall Operations strategy.
• Identify, design, qualify, document and implement automation test and assembly equipment solutions to be used in manufacturing.
• Document all aspects of the equipment, including its requirements, design, operation, and qualification in compliance with Good Manufacturing Processes (GMP).
• Perform design reviews for new equipment and tooling developed.
• Execute equipment design and process verification/validation, including IQ/OQ/PQ activities to allow production release of new equipment.
• Drive continuous improvement projects to increase manufacturing yields, improve test coverage, diagnostic capability, productivity, and error proofing.
• Utilize statistical tools to develop reports of process performance and identify areas of manufacturing improvement.
• Determine the root cause of equipment and system test failures.
• Maintain BOMs for test fixtures, tools or aids. Maintain spare equipment, hardware/software and computer configurations.
• Understand and adhere to the PROCEPT BioRobotics’ Quality & EHS policies.

QUALIFICATIONS (Education, Experience, Certifications)

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• MSME/MSEE Mechatronics or Mechanical engineering with 10+ years related experience.
• Prior hands-on Equipment Engineering experience supporting high volume manufacturing.
• Experience working in a medical device company or other regulated business.
• Experience leading multidisciplinary Engineering teams.
• Ability to work cross functionally.
• Experience working with external partners for equipment development.
• Experience using advanced analytical tools for problem solving.

MANAGERIAL RESPONSIBILITIES

• Directly supervises managers and/or engineers in the Equipment & Automation team. Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

PHYSICAL DEMANDS & 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.
• The employee may occasionally lift and/or move up to up to 50 pounds.
• The employee will be exposed to engineering labs, a machine shop, and manufacturing clean rooms. The environment is subject to moderate noise from machinery (ie machine shop equipment, the PROCEPT Aquablation unit, computer equipment, printers, etc.), for which proper hearing protection may be assigned and worn.
• The employee will occasionally be exposed to clinical operating rooms, for which proper personal protection equipment will be assigned and worn.