Director of Consumable Manufacturing & Engineering

Company: Baebies Inc.
Location: Durham
Posted on: January 27, 2023

Job Description:

Description: Baebies is a medical device company that develops and commercializes newborn screening and near-patient testing products for children and adults to enable early disease detection and comprehensive diagnosis. Guided by the vision that everyone deserves a healthy start," our mission is to save lives and make lives better for all by bringing new technologies, new tests, and new hope to children, parents, adult patients, and healthcare professionals worldwide. Job purposeThe Director of Consumable Manufacturing and Engineering directs the activities of both the consumable manufacturing and manufacturing engineering functions. The position sets the tone for daily operations and leads the engineering team to improve quality, productivity and manufacturing capacity. This leader envisions the future and leads our operations transformation and growth.Duties and responsibilities

• Direct reagent and consumable manufacturing at an ISO 13485 registered medical device manufacturer.
• Ensure that consumable production meets delivery, quality, and cost requirements.
• Lead daily operations through the Manufacturing Supervisors.
• Plan and implement a continuous improvement program for quality, productivity and cost.
• Develop productivity and quality metrics. Develop systems and processes to track and optimize productivity. Establish accurate manufacturing cost standards.
• Work with other functional departments to calculate current and planned COGS.
• Work collaboratively with the Supply Chain Manager to ensure that appropriate material inventories are maintained and that weekly, monthly and quarterly production plans are in place to meet customer demand and deliver manufacturing efficiency.
• Lead the S&OP demand planning process.
• Track performance and provide monthly and quarterly performance data and presentations.
• Ensure operations compliance to ISO 13485 and IVDR.
• Provide process quality leadership and ensure that manufacturing meets cGMP requirements.
• Lead the team to pursue process fundamental understanding and direct process improvement efforts.
• Ensure that product quality issues are resolved quickly.
• Ensure that QMS documentation reflects current manufacturing and engineering practices and lead the team to improve the QMS through the application of a risk-based approach to quality system design. Ensure that appropriate process controls are in place.
• Lead the team to investigate and resolve non-conformances in a timely fashion. Ensure that CAPAs are prepared and completed in a timely manner and that they thoroughly resolve failure root causes.
• Manage Manufacturing Engineering resources and provide technical leadership for the team.
• Using engineering resources, assess current manufacturing processes and direct activities to improve manufacturing process capabilities. Execute a program to transform the manufacturing process.
• Drive efforts to reduce COGS. Create a process improvement and capacity increase strategy and manage engineering resources and projects to achieve the strategy. Increase manufacturing capacity through selective process reengineering and introduction of cost effective automation.
• Ensure that production equipment is maintained and direct required facility and process equipment changes to support growth.
• Direct the improvement of process data capture and reporting systems and lead the team toward process improvement using data analytics and improved process controls.
• Gain process knowledge and apply learnings to direct the manufacturing and manufacturing engineering functions. As required, lead problem solving initiatives and teams.
• Collaborate with the Product Lifecycle Management team and product development teams. Provide DFM input and ensure that design and technology transfers are completed in a timely manner. Lead Operational Readiness teams and efforts and manage new product manufacturing launches.
• Ensure that new processes are validated. Ensure that pFMEAs are in place and maintained and that process control plans reflect process risk. Drive engineering efforts to improve manufacturing systems and reduce manufacturing risks.
• Lead the organization with a Continuous Improvement mindset. Act as a cultural leader for Operations, leading by example and acting with integrity.
• Recruit, select, on-board, train, develop and retain qualified personnel. Maintain open communications and demonstrate a passion for and commitment to success.
• Build relationships across all levels within operations and collaborate with other functional departments to deliver on the company mission.
• Maintain excellent communications with Sales & Marketing regarding demand, QA regarding NCs and CAPAs and quality improvement initiatives, and Finance regarding financial performance. Requirements:QualificationsEducation
  • BS in Engineering, MS or MBA desired
  • Classwork in chemistry, biochemistry or material science desiredSkills:
    • Excellent verbal and written communication skills
    • Strong interpersonal skills and ability to motivate and build consensus
    • Demonstrated technical problem solving skills
    • Demonstrated leadership skills
    • Strong analytical and problem-solving skills
    • Demonstrated skills using MS Excel and MS ProjectExperience:
      • 10+ years' progressive experience in high technology or medical device manufacturing
      • 5+ years managing technical / engineering direct reports
      • 3+ years managing manufacturing
      • 3+ years in a senior manager or director level position
      • Functional department strategic planning and tactical execution
      • Experience with FDA-regulated IVD manufacturing (ISO 13485 and IVDR)
      • Desired experience with automated assembly processes
      • Broad exposure to multiple manufacturing technologies
      • Demonstrated project management experienceWorking conditionsGeneral office environment.Works closely with the VP of Operations to define and realize the company manufacturing strategyPhysical requirementsLifting up to 20 pounds. Sitting and/or standing in a stationary position for long periods of time. Viewing a computer screen for long periods of time.Direct reportsManufacturing SupervisorsEngineering SupervisorManufacturing Quality Support Engineers Compensation & BenefitsBaebies offers a dynamic and welcoming work environment surrounded by intelligent, driven, and creative people. Guided by the vision that everyone deserves a healthy start, our team is devoted to our customers and to advancing technology in early disease detection and comprehensive diagnosis. At Baebies, we look for people who are innovative, dedicated to our mission, and constantly striving to improve the status quo. In addition to competitive, market-driven compensation, Baebies provides a comprehensive employee benefits package including: - 100% employee premiums for Medical & Vision coverage - 100% employee and family premiums for Dental coverage - 401K Matching - Stock Options - 4 Weeks PTO - 14 Paid Holidays per year - Paid Employee Life Insurance - Onsite free gym membership & classesDiscount Pet & Legal InsuranceFertility & Family Support - . . . Much more! Baebies, Inc. is an equal opportunity employer. NO RECRUITERS OR AGENCIES, PLEASE.PI202099174

Keywords: Baebies Inc., Durham , Director of Consumable Manufacturing & Engineering, Executive , Durham, North Carolina