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Integer Holdings Corporation

Medical device CDMO for cardiac devices

Manager Engineering

Manufacturing EngineeringPosted on Nov 11
Full-timePlymouth, MN, USAIn-person

About the Job

Requirements

  • A Bachelor of Science in an engineering or technical field is required; a master's or PhD is preferred.
  • At least 10 years of experience, including at least 5 years in the medical device industry.
  • Strong leadership skills and the ability to multitask and prioritize projects.
  • Knowledge of ISO and regulatory standards is required.
  • Six Sigma Black Belt certification is preferred.

Responsibilities

  • Provide hands-on Manufacturing Engineering support for Operations, interact with customers, and support quality systems engineering and process engineering.
  • Adhere to company values and all safety, environmental, security, quality, regulatory, policy, and operating procedure requirements, including Quality Management Systems, U.S. Food and Drug Administration regulations, and other regulatory requirements.
  • Identify, track, resolve, and communicate major new product ramps and facility cost-reduction initiatives.
  • Lead the development and implementation of Quality and Regulatory requirements, including company policies, procedures, and applicable regulatory requirements.
  • Plan and develop resources to execute Process and Test Method Validations (IQ, OQ, PQ, PPQ) in accordance with company procedures and guidelines.
  • Communicate procedures, policies, improvement ideas, technical information, and recommendations within the company and with outside suppliers, partners, and customers through formal and informal interactions.
  • Prepare or review accurate, complete, and effective documentation using available engineering tools and templates, including specifications, manufacturing procedures, engineering change orders, technical reports, and analyses.
  • Apply and promote Lean manufacturing techniques to improve cycle times and process flows; identify and direct improvement efforts to reduce waste in manufacturing and business processes.
  • Use structured problem-solving techniques and statistical methods for data-driven analysis and decisions.
  • Lead DMAIC Six Sigma approaches to solve issues and reduce variation in manufacturing and business processes.
  • Plan, execute, and manage project activities with cross-functional teams, including finance, human resources, operations, quality, and sales. Projects may include new product development and introduction, manufacturing transfers, continuous improvement, cost reduction, quality improvements, and sales opportunities.
  • Mentor junior staff and motivate cross-functional teams, influencing internal and external members to achieve business results.
  • Lead staff performance management activities, including objective setting, performance reviews, appraisals, coaching, and individual development plans.
  • Apply engineering skills, approaches, and knowledge.
  • Perform other duties as required.

Desired Qualifications

  • A master's degree or PhD.
  • Six Sigma Black Belt certification.

About the Company

Integer Holdings Corporation

Medical device CDMO for cardiac devices

Integer Holdings Corporation is a large medical device CDMO that serves cardiac rhythm management, neuromodulation, and cardiovascular markets. It designs, develops, and manufactures device components and subassemblies through its brands Greatbatch Medical, Lake Region Medical, and Electrochem. The company differentiates itself by its scale, broad capabilities across multiple medical specialties, established brands, and global manufacturing footprint, enabling reliable supply for device makers. Its goal is to help medical device companies bring safe, effective technologies to market and improve patients’ lives worldwide.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Wilmington, DE
Founded
1940

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