Manufacturing Process Development Engineer

30 Jun 2024

Vacancy expired!

Title: Manufacturing Process Development EngineerDuration: Full-time / Direct HireLocation: San Jose, CA

JOB OVERVIEW This position is responsible for aspects of the process design and development of a project with a focus on innovative medical devices that address the customer needs for a complete procedural solution. This role complies with FDA QSR (21 CFR 820), and ISO 13485 requirements and adheres to the Quality Management System (QMS).

ESSENTIAL FUNCTIONS: Designs fixtures, tools, and machines used to manufacture products. Oversees the development of new processes, methods, and production controls. Maintains knowledge of new and developing manufacturing technology, equipment, and applications; applies this knowledge to recommend and implement new technology and processes. Perform engineering and data analysis for activities such as validations and engineering studies including DOEs and root cause investigations. Generate and review process documentation including but not limited to Manufacturing Process Instructions (MPI), Bill of Materials (BOM), and Lot History Records (LHR). Generate and execute Engineering Change Orders (ECO). Identify and implement process improvements to increase quality, capacity, and efficiency, while reducing waste. Monitor process performance using Statistical Process Control (SPC), and other engineering principles. Communicate with customers to understand project needs and set expectations for deliverables. Reviews production program equipment, hardware, and tooling; make recommendations for repairs or replacement. Installs new equipment and ensures that it operates correctly; trains others to operate new machinery. Responsible for ensuring personal and company compliance with all Federal, State, local, and company regulations, policies, and procedures. Responsible for communicating business-related issues or opportunities to the next management level. Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety, and Environmental practices and that all resources needed to do so are available and in good condition.

Qualifications Bachelor's Degree in Mechanical Engineering, Biomedical Engineering, or related field is required. Master's Degree in Mechanical or Biomedical Engineering or related field is preferred. At least 1+ years of relevant Engineering experience - MUST Knowledge and experience in catheter design are preferred. Experience with CAD software such as AutoCAD or SolidWorks is preferred. Knowledge and experience in development processes and in documentation writing are required. Experience with statistical analysis and design of experiments (DOE) preferred. Ability to use PC and associated software is required. In-depth knowledge of materials and metals is preferred. Knowledge of Good Manufacturing processes and Good Documentation Practice

We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

  • ID: #43709961
  • State: California Sanjose 95101 Sanjose USA
  • City: Sanjose
  • Salary: US110000 - US120000 per annum
  • Job type: Permanent
  • Showed: 2022-06-30
  • Deadline: 2022-08-28
  • Category: Art/media/design