Senior Manufacturing Engineer

East Bay, (none selected) | Direct Hire

Post Date: 08/22/2016 Job ID: 3036 Industry: Electrical/Electronic Manufacturing

ESSENTIAL DUTIES AND RESPONSIBILITIES

Responsibilities will include:

  • Design efficient line layout and process flows for complex assemblies

  • Experience deploying DFT and/or Lean methodologies

  • Design and develop new methods and processes for the manufacturer of new or existing products

  • Identify, design, or purchase, and implement manufacturing aids (fixtures, jigs, tools, etcs) 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 & 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 hi-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

SUPERVISORY RESPONSIBILITIES

As needed.

KNOWLEDGE AND SKILL REQUIREMENTS:

  • Minimum of 5 years of related experience (preferably in the medical device industry)

  • Product Mechanical Design experience with small, tight tolerance, machined components

  • Proficient with Solidworks for product mechanical design as well as tool/fixture design

  • Start-up medical device experience preferred

  • Demonstrated ability to thrive in a fast paced dynamic environment


 


 


 


 


 


 


 

Additionally, the ideal candidate will possess the following:

  • Must be able to follow established policies and 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:

  • BS in Mechanical Engineering is preferred and/ or equivalent experience

  • 7+ years in process/manufacturing engineering of medical device products ideally with both, start up and large company experience

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals withdisabilities to perform the essential functions.

  • Combined sitting, standing and walking throughout the day to accomplish tasks.

  • Occasional reaching, stretching, pushing, pulling, stooping or crouching.

  • Manual dexterity used frequently with repetitive finger motion.

  • Occasional lifting up to 50 pounds.

  • Hearing and speaking required regularly.

  • Specific vision abilities include close and distance vision, depth perception, peripheral vision and ability to adjust focus.

  • Overtime hours as needed.

 

 


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