Pitchbook

Manufacturing Manager

Pitchbook • $110K — $130K *
Dallas, TX 75217In-Person
Manufacturing & Automotive
5 - 7 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's or Graduate Degree in Engineering, Operations Management, or related field.
  • 5 years of experience in FDA/ISO 13485 regulated Medical Device Manufacturing.
  • Deep understanding of FDA/ISO 13485 QMSR requirements.
  • Experience managing contract manufacturing of medical products.
  • Knowledge of process validation and risk management.
  • Effective communicator with a proven track record in mentoring teams.

Responsibilities

  • Lead Manufacturing Engineering and Procurement teams.
  • Establish operational goals and departmental performance KPIs.
  • Ensure regulatory compliance during FDA and ISO inspections.
  • Develop and validate manufacturing processes and risk management plans.
  • Manage design transfers of new products to contract manufacturers.
  • Conduct Sales and Operations planning meetings for product delivery.
  • Oversee investigations and corrective actions for nonconformance issues.
  • Support cross-functional teams on New Product Development projects.

Benefits

  • Collaborative work environment focusing on teamwork.
  • Opportunities for professional development and career growth.
  • Exposure to a range of projects within the medical device industry.
  • Flexibility to engage in hands-on processes during peak times.
Full Job Description
Position Summary:

Spectral AI is seeking an experienced team-oriented Manufacturing Manager to lead Manufacturing and Procurement operations of our medical products. The position will report to the General Manager and will collaborate with contract manufacturers, suppliers, and internal cross functional teams to ensure the efficient production of safe products that meet customer requirements.

Essential Duties and Responsibilities:
  • Provide overall leadership to the Manufacturing Engineering and Procurement teams.
  • Establish operational goals/strategies and related departmental performance KPI's.
  • Responsible for Regulatory compliance and representing Manufacturing and Procurement operations in periodic ISO 13485, FDA, and State of Texas compliance inspections.
  • Responsible for manufacturing process development, process risk management and process validation activities.
  • Manages successful design transfer of new products to contract manufacturers.
  • Lead Sales and Operations planning meetings to ensure on time delivery of high quality, safe products that meet customer requirements.
  • Develop department budgets and manage expenses and capital needs within budget guidelines.
  • Coordinate timely investigations, root cause analysis and implementation of corrective/preventative actions to address CAPA's and nonconformances related to Manufacturing/Procurement.
  • Support internal cross functional teams related to New Product Development, Sustaining Engineering, Quality Improvement and other projects as assigned by Senior Leadership.
  • Build a highly skilled, highly regarded and motivated customer focused team that mentors individual members to achieve their full potential.
  • Develop improvement strategies based on the business goals and aligned with Lean Manufacturing principles in compliance with applicable agency regulations.

Required education and experience:
  • Bachelor's or Graduate Degree in Engineering, Operations Management or related field or equivalent experience.
  • 5 years of FDA/ISO 13485 regulated Medical Device Manufacturing and Supply Chain industry experience supporting production of FDA Class II or III medical products.
  • Process Validation
  • Deep understanding of FDA/ISO13485 QMSR requirements with direct experience representing Manufacturing/Supply Chain operations in periodic surveillance audits.
  • Demonstrated experience with managing contract manufacturing of medical products.
  • Experience working in a multidisciplinary environment producing complex high quality medical products.
  • Effective communicator with a successful track record of mentoring and building effective teams.
  • Position requires a hands on approach. Must be willing to pitch in during peak activity to ensure team objectives and timelines are met.

Preferred Qualifications:
  • Experience with UL/MET Electrical Safety compliance inspections and ability to support Contract Manufacturer to maintain compliance.
  • Lean 6 Sigma Green Belt certification or higher.
  • Experience utilizing NetSuite ERP, and Greenlight Guru EQMS Systems preferred.
  • Excellent verbal and written communication skills

Physical Requirements:

The physical demands described below are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Employee routinely is required to sit; walk; talk and hear; use hands to keyboard.
  • The employee is occasionally required to move around the office.
  • Specific vision abilities required by this job include close vision, color vision, depth perception, and ability to adjust focus.
  • The employee may occasionally lift and/or move up to 30 lbs.

Travel:
  • 25% of travel time expected for the position to visit contract manufacturing/supplier locations; both local and national travel may be required.

About Pitchbook

PitchBook is a financial data and software company that provides research, analysis, and data on private equity, venture capital, and M&A transactions. The company's platform offers a range of tools and services, including market research, deal sourcing, due diligence, and portfolio management. PitchBook serves a variety of clients, including investment banks, private equity firms, venture capital firms, and corporate development teams. The company was founded in 2007 and is headquartered in Seattle, Washington.
Learn more about Pitchbook
Size
1,000 employees
Industry
Finance & Insurance
Founded
2007
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Pitchbook

More Manufacturing & Automotive Jobs

Find similar Manufacturing Manager jobs:

NationwideDallas, TX