TEMP Manufacturing Engineer

Company: InBrace
Location: Newport Beach
Posted on: August 6, 2022

Job Description:

InBrace is a flat, fail-fast organization changing the face of orthodontics starting with a behind-your-teeth, teeth straightener -- driven by the revolutionary Smartwire - . InBrace provides the clinically superior results orthodontists love & the aesthetics and comfort that have never been possible - until now.JOB SUMMARYThe TEMP Manufacturing Engineer I is to work closely with R&D, Quality, and Operations in the development/improvement of the processes necessary to produce new/existing products in a manufacturing environment. This role will manage product builds, develop new manufacturing processes, implement, and qualify production equipment and methods, troubleshoot production line issues, generate testing protocols and reports, and work with minimal direction. The job requires excellent communication skills and comfort with working in a fast-paced, rapidly growing startup environment. If you are looking for a challenge and want to make a meaningful contribution, then this is the perfect role for you.POSITION RESPONSIBILITIES

• Manage builds for existing or new product in a pilot or production setting, including: *Equipment and process validation. *Preparing manufacturing documentation. *Coordination with production planning. *Training of operators. *Identifying, testing, and procuring materials for builds. *Designing and installing fixtures. *Troubleshooting production and equipment issues.
  • Comply with applicable FDA and international regulatory laws/standards.
  • Support Quality and production in non-conformance investigations and dispositions.
  • Identify, evaluate, and implement/qualify custom and/or off-the-shelf tooling/fixtures/equipment (IQ/OQ/PQ, support, design) for improving manufacturing throughput/quality.
  • Apply statistical and analytical methods such as SPC, SQC, and DOE.
  • Participate on project teams tasked with new process/product development and the successful transfer into manufacturing.
  • Other duties as assigned or required. DESIRED/PREFERRED QUALIFICATIONS
    • Process background (development, capability, optimization, validation) within a regulated industry.
    • Experienced with modeling software such as AutoCAD, Solidworks, and/or 3matic.
    • Ability to draft technical documents (i.e. manufacturing and test procedures).
    • Knowledge in 3D print/additive manufacturing technologies including polymers and metals.
    • Knowledge in materials associated with medical devices.
    • Knowledge in processes associated with medical manufacturing.
    • Highly organized with ability to manage multiple projects.
    • BASIC QUALIFICATIONS
      • Bachelor's Degree or equivalent in Engineering required - Mechanical, Industrial, Manufacturing, Materials, or related, with 2-3 years of experience.
      • Problem solving methodology, root cause analysis, and GDP (Good Documentation Practices).
      • Good computer skills in usage of MS Office Suite.
      • Good documentation, communication and interpersonal relationship skills including negotiating and supplier relationship skills.
      • Understanding of statistical techniques.
      • Ability to perform complex troubleshooting
      • Previous experience working with lab/industrial equipment required.
      • Working knowledge of LEAN and SIX Sigma methodologies.
      • Ability to learn & teach new technology and methods.ABOUT INBRACEInBrace was started because a team of engineers, bone biologists and orthodontists believed teeth-straightening shouldn't have to make you look worse before you look better. They invented a personalized and programmed Smartwire that's placed behind teeth to gently improve smiles on autopilot. The DNA of that original team of dreamers and doers persists in today's world-class organization that is rapidly commercializing the future.InBrace has no monthly tightening's, no tray changes, and no one knows you're in treatment. That's why we see no competition.There are hundreds of millions of people who could benefit from teeth-straightening who haven't started yet because they didn't have a solution for their lifestyle until InBrace.Eat, drink, brush and floss normally while you share your improving smile with the world. Designed for you. Made for real life.WHO WORKS AT INBRACEWe look for team-members who align with our InBrace core values:We go above and beyondOperate with integrityWe get it doneWe are passionate about improving people's lives and have a collaborative, cross functional team of dreamers and doers. The ideal InBrace team-member has a head for strategy and a burning desire to execute with precision.InBrace has world-class functional teams of orthodontics, engineering, regulatory, software, marketing, sales design, training, human resources, regulatory, and legal.We champion the right business decision over the need to be right. We are highly transparent, team-centered organization that works to provide team-members with the tools they need to be successful. We are looking for a candidate who has an insatiable need to win, the stamina for a long race, the ability to partner with team-members in a "win-together" culture, and the dexterity to wear multiple hats as the InBrace organization continues to grow rapidly. You will need to work with senior management and junior employees in a fast-paced and respectful environment.

Keywords: InBrace, Newport Beach , TEMP Manufacturing Engineer, Engineering , Newport Beach, California