Sr Manufacturing Engineer

Palo Alto, CA | Direct Hire

Post Date: 09/27/2017 Job ID: 3005 Industry: Software/Hardware

This position is responsible for contributing to the design, planning and implementation ofmanufacturing systems, equipment and processes for bringing new technology into the market. This position will be able to work under general supervision and direction and be able to recommend changes in designs or project activities to improve the Company’s performance in meeting customer needs.  Other areas include reviewing documents as specified in Document Control SOPs, executing project plan activities to meet project milestones and comply with Design Control and lab notebook procedures in accordance with Company standards.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES

Responsibilities will include:

  • Design efficient line layout and process flows for complex assemblies.
  • Proficiently eliminating NVA.
  • Deploying DFT and/or Lean methodologies.
  • Design and develop new methods and processes for the manufacture of new or existing products.
  • Identify, design, or purchase, and implement manufacturing aids (fixtures, jigs, tools, etc.) to reduce manufacturing costs associated with direct labor, scrap and rework.
  • Perform DOE-type engineering and optimization studies.
  • Perform Process Validation tasks related to new products and processes (IQ, OQ, PQ, PPQ).
  • Selection of equipment to support manufacturing processes, including scale up of new and prototype processes.
  • Identify product design changes to improve quality and reduce cost.
  • Evaluate processes to identify areas to improve quality, cost efficiency and employee safety.
  •  Author test protocols, reports and manufacturing documents related to new processes.
  • Troubleshoot product returns for root cause, identify possible solutions, and test.
  • Interface daily with in-house and contract manufacturing engineering teams to identify/resolve problems and implement solutions to stabilize product.
  • Key contributor in the design and roll out of new product introduction into high-volume production.
  • Apply and reinforce Design for Manufacturing (DFM) strategies to address ease of manufacturing, cost and quality goals.
  • Knowledge of FDA regulated medical device product manufacturing process; experience with introduction of new products, and development of new manufacturing processes.
  • Thorough understanding of FDA, GSR, and cGMP requirements.

QUALIFICATIONS

  • Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards
  • Ability to perform activities to support product development, administration, manufacturing, and other Company activities or other duties as assigned
  • Must be able to follow established policies and procedures, create new procedures, and comply with regulatory requirements
  • Must be a positive, energetic team player, and an advocate for product excellence and quality
  • Must be hands-on, results-oriented, who is a strong team player, excellent communicator, and comfortable in an entrepreneurial environment
  • Must have the ability to recognize problems, recommend and implement solutions
  • Must be well organized and possess excellent organizational skills and the ability to handle multiple responsibilities concurrently
  • Must be flexible and adaptable in a fast-paced, start-up environment
  • Must work well with others and be a team player
  • Must possess a “can-do” attitude
  • Must have the ability and desire to be proactive not just reactive; a questioning mindset

 

EDUCATION AND EXPERIENCE

  • Bachelor’s degree in mechanical or biomedical engineering or related field or equivalent work experience required
  • 5+ years of process/manufacturing engineering of medical device products experience required

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