Demo

Manufacturing Engineer

Raise
Rancho Cordova, CA Full Time
POSTED ON 3/23/2025
AVAILABLE BEFORE 4/22/2025

Job Description

Manufacturing Engineer

  • Full-time, permanent position
  • Rancho Cordova, Sacramento County, California, USA

Are you a seasoned Manufacturing Engineer ? Are you looking for an opportunity to join a team of experienced professionals and work for a stable and quality-focused company?

If this sounds like you, we want to hear from you!

We’re Raise, and we’ve joined forces with our client, an industry leader within the medical device sector. They specialize in the development and commercialization of automated cell processing technologies for cell and gene therapy fields.

What you’ll be doing

As the new Manufacturing Engineer , you’ll be responsible for providing support for cleanroom manufacturing operations, new technology introduction, manufacturing development, process validation and day-to-day manufacturing activities. This position requires knowledge of the production and process development of medical devices. The position involves the sustaining engineering activities for existing products, installation of manufacturing equipment and transfer of new technologies to production. Experience needed in relevant validation protocols (IQ, OQ, PQ) involving all aspects of process and product validation, i.e. manufacturing process instructions, test protocols, manufacturing software, design of experiments, engineering studies, root cause analysis and the creation of pFMEA’s. This position will frequently require participation in cross-functional teams in which the engineering activities are coordinated through project plans. The manufacturing engineer is required to be comfortable with providing technical leadership for operations personnel and presentation of technical data to management.

Responsibilities

Apply engineering principles to the manufacturing of medical devices in a cleanroom environment. This position will place an emphasis on knowledge of plastics methods of assembly for small to medium scale volumes. Essential activities will include :

  • Improve product manufacturability.
  • Perform engineering analyses as it pertains to troubleshooting, verifications, writing and conducting test protocols.
  • Establish manufacturing solutions.
  • Initiate and review manufacturing process instructions (MPIs).
  • Participate in Material Review Board (MRB) to address nonconforming assembly / components.
  • Conduct feasibility studies.
  • While working as a member of a multi-functional project team, changes to products to be developed in adherence to specified Design Control and Product Development Processes while achieving performance that satisfies product specifications within planned time frames.
  • Participate in transfer-to-manufacturing activities and establishment of process validation for product assembly.
  • Work with external suppliers (Contract Manufacturers, distributors, etc.) to sustain existing products.
  • Effectively communicates verbally and in writing with Engineering Management as well as all functional areas within the organization.
  • Knowledge of Good Documentation and Lab Notebook Practices.
  • The Details

    This is a full-time, permanent opportunity located at a state-of-the-art facility in Rancho Cordova, nestled in vibrant Sacramento County, California, USA. You'll work Monday to Friday within the facility. You’ll receive a competitive base salary in the range of $90,000 - $120,000 / per year, (commensurate with your experience). In addition to this, they offer comprehensive benefits, including health and dental coverage, a 401(k) plan, and vacation time, ensuring a balanced and rewarding career.

    Qualifications

  • Bachelor of Science in Mechanical Engineering or related field
  • 5 years related experience in a similar role within a highly regulated manufacturing environment. Preference will be given to candidates in the medical device manufacturing sector
  • Experience with SolidWorks parts, assemblies and drawings. Inventor and AutoCAD knowledge is considered a plus
  • Experience with relevant validation protocols - Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), involving all aspects of process / product validation
  • Experience with ISO 13485 and Process Failure Mode and Effects Analysis (pFMEA’s)
  • Strong analytical and problem-solving skills
  • Solid understanding of plastics and metals fabrication and methods of assembly
  • Ability to write technical documents in support of essential job functions
  • Ability to define the objectives, requirements, and assumptions necessary to structure and schedule a small project
  • Effective communication, teamwork, and time management
  • Familiar with medical device risk management a plus
  • Experience with medical devices and systems that incorporate mechanics, electronics and software is considered a plus
  • Your Application

    We value diversity and inclusion and encourage all qualified people to apply; however, only those selected for an interview will be contacted.

    Salary : $90,000 - $120,000

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