Risk Control Director Jobs in Rochester, IN (NOW HIRING)

SUMMARY OF POSITION:   Responsible for leading the development and improvement of internal transactional and manufacturing processes using lean tools, validation activities, and proactive process control measures. The position will lead and participate in cross-functional teams facilitating all activities associated with process development, process improvement, and new product launches. Leads and supervises the day to day manufacturing engineering team and projects. 

ESSENTIAL FUNCTIONS: 

• Lead and supervise projects and the manufacturing engineering team supporting site on time delivery, continuous improvement (CI) and quality objectives
• Manages multiple tasks/projects and schedules priorities for self and manufacturing engineers. Responsible for all manufacturing engineering activities within the department.
• Directs team to work with cross-functional teams within site and international case & tray sites in developing or improving processes, new production introduction and new equipment deployment.  Will also direct personnel to work with operations and regulatory teams to ensure processes are validated and documented.
• Lead process improvement activities for department and site process improvement initiates
• Develop and monitor compliance within department to meet internal procedures, ISO and FDA regulations
• Effectively and proactively perform continuous improvement on existing processes.
• Lead process flow development including value stream mapping, process, and product characteristics.
• Lead pFMEA development and team discussions along with managing the risk mitigation activities and testing.
• Approve and support engineering test protocol development and reporting for process characterization and process testing.
• Oversee machine identification, acquisition, and implementation activities.
• Approve and participate in part specific, equipment, and process validation activities.
• Support and/or approve the development, documentation, and execution of validation protocols and final reports (Installation Qualifications / Operational Qualification / Process Qualification - IQ/OQ/PQ)
• Lead and direct team in support of customer complaint investigations and/or corrective and preventive actions (CAPAs)
• Support new product development projects and teams, supply chain development and postproduction meetings, as necessary.
• Work proactively with the team to share and establish best practices and lessons learned.
• Foster close and productive relationships with manufacturing engineering team, cross-functional counterparts and site management team
• Understand, develop, and maintain project schedules for all projects that are within the department.
• Serve as point of contact for technical interface between production and engineering
• May act as site OpEx leader
• Develop performance management and professional development of direct reports including communicating responsibilities and priorities of necessary support to each department. Set goals for each employee and monitor their activity through employee development.
• Develop standard operating procedures and systems for departmental operations.
• Develop, monitor and report on departmental metrics.
• Develop and present updates in management meetings.

EXPERIENCE / EDUCATION:             

• Bachelor's degree in Mechanical Engineering or Biomedical Engineering.
• Minimum of seven years experience, or education background, with blueprint reading, GD&T, working knowledge of short run process control methods, statistical analysis, DOE, ISO standards and FDA quality system regulations.
• Previous experience in a leadership position required.
• Windows-based computer knowledge required and working experience with CAD systems preferred.
• Knowledge of Design for Manufacturability (DFM) principles, biocompatibility requirements for materials, ISO 13485 and US QSR 21 CFR, Part 820 Medical Devices, and basic understanding of the human anatomy preferred.
• Thorough working knowledge of various metal and polymer materials, as well as testing specifications, plant engineering, industrial engineering, manufacturing practices, project management, and lean principles.

SKILLS:    

• Supervisory and interpersonal skills with the ability to cultivate and maintain cooperation from others.
• The ability to develop comprehensive project plans and schedules in support of customer, quality and operations improvement objectives.
• Excellent communication skills.
• Able to work with minimal supervision and actively participate in a team oriented, continuous improvement, manufacturing environment.
• Premiere organizational skills and attention to detail required.
• Strong leadership, ability to handle multiple tasks and prioritize in a fast-paced environment.
• Strong problem solving, decision making, and process improvement skills.

PHYSICAL DEMANDS AND WORK ENVIRONMENT:   The physical demands and work environment characteristics described here are representative of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Physical demands: While performing the duties of this job, the employee is required throughout the workday to stand; walk; sit; use hands to handle objects; reach with hands and arms; stoop; talk or hear.  Specific vision abilities required by the job include close vision and may also include color vision; depth perception; and the ability to see print in various sizes and formats.  May be required to climb stairs, kneel or crouch.  May be regularly required to pull and push up to 15 pounds and occasionally lift boxes up to 25 pounds.
• Work environment: Work performed in an office environment.  The noise level in the work environment is usually low.