Manager Supply Chain Engineering
Manager Supply Chain Engineering
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$ 145000 - 155000
1 Vacancy
Job Description
About Ceribell
Ceribell is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions. The Ceribell System is a novel pointofcare electroencephalography (EEG) platform specifically designed to address the unmet needs of patients in the acute care setting and is being used in hundreds of community hospitals large academic facilities and major IDNs across the country. Our entire team is driven by a shared commitment to transforming the landscape of critical care through our rapid seizure detection technology come join the movement!
Position Description:
Ceribell is seeking an experienced Manager Supply Chain Engineering to lead our supplier engineering team. This role focuses on overseeing supplier qualification engineering capability development and ensuring suppliers meet stringent quality and compliance standards. The Manager Supply Chain Engineering will be responsible for managing supplier relationships (technical) and driving continuous improvement initiatives to optimize manufacturing processes.
This position requires a proven track record in supplier management team leadership compliance with FDA and ISO standards and collaboration with crossfunctional teams including Quality Product Design R&D and Operations. This is a key leadership role in ensuring that our supply chain delivers highquality reliable and costeffective components for our products.
Responsibilities:
Supplier Qualification and Management:
- Oversee the supplier qualification process ensuring new and existing suppliers meet engineering quality and production standards.
- Conduct and lead onsite audits at overseas supplier locations to evaluate manufacturing capabilities compliance with FDA 21 CFR Part 820 and ISO 13485 standards and overall quality systems.
- Develop and implement robust qualification strategies including process capability studies First Article Inspections (FAI) and Production Part Approval Process (PPAP).
Technical Assessment and Support:
- Lead technical reviews to assess supplier engineering capabilities including tooling design automation systems and highvolume manufacturing readiness.
- Provide guidance to suppliers in resolving quality and process issues emphasizing continuous improvement and process optimization.
- Identify and drive opportunities for automation and process enhancements at supplier facilities.
New Product Introduction (NPI) Engineering Support:
- Support the successful introduction of new products by ensuring suppliers are prepared for production at required quality and capacity levels.
- Work closely with R&D and Product Design teams to ensure supplier capabilities align with new product requirements.
- Drive Design for Manufacturability (DFM) and Design for Assembly (DFA) discussions to optimize supplier processes for NPI.
- Oversee supplier validation and qualification activities for new product launches ensuring seamless transitions from development to production.
- Establish scalable supplier processes to support volume rampup and longterm manufacturing success.
CrossFunctional Collaboration:
- Partner with Quality Product Design R&D and Operations teams to align supplier capabilities with product specifications and regulatory requirements.
- Lead crossfunctional Design for Manufacturability (DFM) reviews to ensure supplier processes can meet product design requirements at scale.
- Act as a key liaison between suppliers and internal teams to resolve engineering and production challenges.
Process Improvement and Compliance:
- Drive supplier process improvement initiatives focused on automation defect reduction and efficiency gains.
- Establish and monitor Key Performance Indicators (KPIs) such as defect rates ontime delivery and yield rates implementing corrective actions as needed.
- Ensure suppliers comply with GMP FDA ISO 13485 and ISO 9001 requirements through strong auditing and qualification processes.
Risk Management and Strategic Sourcing:
- Conduct risk assessments and implement mitigation strategies to address potential supply chain disruptions.
- Lead efforts to qualify secondsource suppliers to reduce risks and improve supply chain resilience.
- Collaborate with Procurement to drive cost reduction initiatives through process optimization and supplier negotiations.
Documentation and Reporting:
- Maintain comprehensive supplier qualification documentation audit reports and corrective action plans.
- Provide regular reports on supplier performance risks and improvement initiatives to senior management.
- Ensure accurate and timely documentation of nonconformance reports (NCRs) corrective actions (CAPA) and other compliancerelated activities.
Team Leadership and Management:
- Lead mentor and develop a team of supplier engineers fostering a culture of technical excellence and continuous improvement.
- Establish team goals provide performance feedback and support career development of team members.
- Coordinate crossfunctional initiatives to enhance supplier qualification and process optimization.
Requirements/Qualifications
Education:
- Bachelors degree in Mechanical Engineering Industrial Engineering Manufacturing Engineering or a related field.
Experience:
- 7 years of experience in supplier qualification manufacturing engineering or process engineering in the medical device industry.
- 2 years of experience in leading and managing teams in supply chain or engineering roles.
- Proven track record of managing overseas suppliers and supporting highvolume production.
- Strong knowledge of FDA 21 CFR Part 820 ISO 13485 and ISO 9001 requirements for medical devices.
- Experience in qualifying suppliers for molding automation and process improvements.
- Experience supporting New Product Introduction (NPI) and scaling supplier processes for mass production.
Skills:
- Strong leadership and people management skills with the ability to mentor and develop highperforming teams.
- Proficiency in quality tools such as FMEA SPC 8D and Root Cause Analysis.
- Indepth understanding of automation systems and process improvement methodologies.
- Excellent problemsolving analytical and project management skills.
- Effective communication and relationship management skills particularly with overseas suppliers.
Willingness to Travel:
- Up to 20 domestic or international travel to supplier locations as require
A candidates final salary offer will be based on their skills education work location and experience and thus it may differ from the posted range. Compensation may also include bonuses consistent with Ceribells corporate compensation plan. Note the above description is not allencompassing and Ceribell reserves the right to change or modify job duties and assignments at any time.
Ceribell is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex (including pregnancy childbirth and related medical conditions) sexual orientation gender identity or expression national origin age marital status disability veteran status or any other characteristic protected by law. Any applicant with a disability who requires an accommodation during the application process should contact to request reasonable accommodation.
In addition to your base compensation Ceribell offers the following:
- Annual Bonus Opportunity Ceribell Equity
- 100 Employer paid Health Benefits for the Employee
- 50 70 Employer paid Health Dental & Vision for dependents (according to plan selection)
- Life & Longterm disability insurance paid 100 by Ceribell
- Monthly cell phone stipend
- Flexible paid time off
- 11 Paid Holidays
- Excellent parental leave policy
- Fantastic culture with tremendous career advancement opportunities
- Joining a missionminded organization!
Compensation Range
$145000 $155000 USD
Required Experience:
Manager
Employment Type
Full Time
