Catheter Manufacturing Engineer II

3 weeks ago

Fremont, United States BioTalent Full time

MAIN PURPOSE OF JOB:

The Manufacturing Engineer is in close collaboration with Operations, NPI Engineering, Design & Development, and Purchasing to support Catheter Manufacturing for the Operations team. You will be involved in the design and development of fixtures and processes to scale manufacturing of catheters. You will be responsible for documentation, and validation of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on process and efficiency improvements, clinical builds, training production, preparation, and execution of process validation for new version of products.


MAIN JOB RESPONSIBILITIES:

We are actively looking for a Manufacturing Engineer II who can bring innovation and creative thinking to the team on catheter-based devices. As a Manufacturing Engineer II, you will be primarily responsible for maintaining, developing, and implementing cost-effective manufacturing processes and methods. You will provide day to day support of the catheter manufacturing floor operations from an engineering perspective. Manufacturing Engineers document processes, implement ideas and solutions to improve assembly operations and reduce costs, develop tooling/fixturing, drive investigations tied to non-conformances. Experience with validations, risk management, and Lean Principles is preferred.


ESSENTIAL RESPONSIBILITIES

  • Develops and implements robust cost-effective manufacturing processes and improves product flow and product quality and safety performance for both sustained and new products.
  • Leads assigned customer transfer of new products to production including establishing assembly time and yield targets, training needs and quality control.
  • Develops, tests and implements tools, fixtures and equipment required for manufacturing processes.
  • Develop and maintain manufacturing process instructions, inspection plans and lot history travelers.
  • Leads creation of manufacturing process validation plans, validation protocols and reports, and implements manufacturing process validations and test method validations.
  • Collaborates with cross-functional teams including customer during development phase(s), and provides inputs and recommendations for design for manufacturability (DFM).
  • Maintains process risk documentation (e.g. PFMEA) to identify potential risks, and implement preventive and corrective actions
  • Manages and/or supports production and test equipment maintenance, qualification and calibration.
  • Performs analysis for cost reduction, and quality and efficiency improvement.
  • Prepares engineering change orders and coordinates the implementation of changes including training production staff.
  • Troubleshoots designs and processes when defects occur, leads investigation to determine root cause and implements effective containment and counter measures.
  • Dispositions non-conforming products and develops required re-work procedures and processes.
  • Communicates with customers regarding process improvements, fixture development, and production changes
  • Perform other responsibilities duties as assigned.


This is not a remote position. The position requires to work onsite and support the production floor daily.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.


POSITION REQUIREMENTS:

Knowledge / Education

  • BS in Mechanical / Biomedical / Industrial Engineering or in an equivalent engineering discipline
  • 3-5+ years of experience in catheter based medical device process development and/or manufacturing engineering
  • Experience with lean manufacturing techniques, value stream mapping, and continuous improvement methodologies highly preferred
  • Experience with new product introduction and interactions daily with customers development teams
  • Solid knowledge of GMP and ISO 13485 regulations
  • Must be able to review and interpret technical drawings and specifications. Proficiency in Solidworks preferred.
  • Strong computer skills, including the MS Office suite
  • Must be able to read, write and speak fluent English, and must possess excellent communication and presentation skills, both written and oral
  • Must have demonstrated organizational skills to manage multiple priorities and schedules.

WHAT WE OFFER

  • A fast-paced work environment
  • Paid time off
  • 401(k) retirement savings with a company match
  • Clean, and well-lit production areas
  • Training and career development, with onboarding programs for new employees and tuition assistance
  • Financial security through competitive compensation, incentives and retirement plans
  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

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