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Biomedical Search Consultants
Published
February 21, 2024
Location
Weston, MA
Category
Job Type

Description

Our client, a medical device and technology developer, has an immediate opening for a Senior Manufacturing Engineer. This role will create and maintain internal and external manufacturing procedures, processes, and fixtures used in the manufacturing of medical devices. This is a working position in a start-up environment and will allow the individual to build a team as the business needs arise.

Responsibilities:

  • Provide DFM and DFT feedback on new products as part of the development team
  • Create product workflows and routings
  • Create work instructions for internal and external use
  • Implement process and design improvements to improve cost, time, and quality
  • Develop, implement, verify, and validate manufacturing processes in support of process flow and value stream mapping improvements for existing and new products
  • Work with quality on verification and validation procedures to support the launch of commercial manufacturing
  • Enhance manufacturing process flow and floor layout to enhance safety, quality, and efficiency
  • Work with the product development team to design manufacturing tooling and fixtures
  • Work with production and quality on creating procedures and processes to manage external contract manufacturers as well as internal production
  • Manage new product introduction and transition from product development to production
  • Act as the point of contact for resolving technical issues at the contract manufacturer and the production floor
  • Other responsibilities as required

Requirements:

  • BS in Engineering or Science
  • Minimum of 7 years of manufacturing experience in the medical device/FDA regulated industry, preferably in the capital equipment and or laser field
  • Prior experience working with contract manufacturing and transitioning products from design to contract manufacturing
  • Working knowledge of the FDA, ISO, and the medical device industry requirements (e.g., FDA QSR, ISO 13485, ISO 14971)
  • Good verbal and written communication skills demonstrated by ability to generate technical reports and presentations for management
  • Competent with use of Microsoft Office Suite
  • Takes initiative and demonstrates leadership and teamwork
  • Ability to work in a fast-paced, dynamic start-up environment
  • Ability to work on multiple projects at the same time
  • Ability to work with minimal supervision
  • Ability to work with all levels within the company
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