Director of Consumable Manufacturing & Engineering
Company: Baebies Inc.
Posted on: January 27, 2023
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
- Lead daily operations through the Manufacturing
- 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
- 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
- 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
- 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
- Ensure that production equipment is maintained and direct
required facility and process equipment changes to support
- 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
- 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
- Maintain excellent communications with Sales & Marketing
regarding demand, QA regarding NCs and CAPAs and quality
improvement initiatives, and Finance regarding financial
- BS in Engineering, MS or MBA desired
- Classwork in chemistry, biochemistry or material science
- Excellent verbal and written communication skills
- Strong interpersonal skills and ability to motivate and build
- 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
- 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
- Experience with FDA-regulated IVD manufacturing (ISO 13485 and
- 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
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