Principal/Advanced Quality Engineer

4 weeks ago

Boston, United States OPT Industries Full time

Company Description:

OPT Industries () is a rapidly growing, venture-backed MIT spinoff company that focuses on building the next generation of additive manufacturing technology. Working at the intersection of automation engineering, computational design, and polymer science, we design and commercially manufacture highly customizable materials and products- everything from medical devices to luxury fashion.

Lead Quality Engineer Role:

Multifaceted, hands-on technical expert, responsible for leading OPT Industries Quality efforts with regards to design quality, manufacturing quality engineering and assurance.     

  • 50% Design of Product/Process Quality, Including Test Method Development  
  • 40% Transfer/Validation and Ongoing Quality Engineering Support
  • 10% QMS Development/Management

Principal Responsibilities:

  • Work directly with customers and OPT's R&D department to develop new product specifications with supporting test methods to evaluate design performance. This includes the creation and ongoing review of Risk Management documentation such as Design Failure Mode and Effects Analysis (DFMEA).
  • Support OPT's R&D team by developing test methods, evaluation standards, and process measurement tools to analyze and improve new materials and manufacturing processes.
  • Provide technical quality leadership to project teams for project decisions and deliverables (Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, Process Validation).
  • Write and execute validations to determine the capability of new products and manufacturing processes as they are transferred from R&D into an industrial scaled manufacturing environment. 
  • Work directly with the manufacturing and engineering team to investigate and correct manufacturing errors, as well as continuously reduce sources of manufacturing variability both in manufacturing processes and product outputs.
  • Lead the organization in deploying a Quality Management System that complies with ISO 9001. Support documentation and compliance cross functionally.

Qualifications:

  • 5+ years of engineering experience supporting technical product/process development and industrialization. This includes experience leading: (1) new product and/or material test method development, and (2) full scale validation of test methods and manufacturing processes
  • Bachelor's degree in an engineering discipline (ME, EE, CHEME).
  • Experience working as a major contributor to large scale multi-departmental product development projects. Ability to lead through influence and resolve quality-related issues.
  • Experience leading process improvement projects using Six Sigma or Lean methodologies.
  • 5+ years working in the chemical, electronics, aerospace or automotive industry

Benefits:

OPT Industries provides the following benefits to all full-time employees: Medical, Dental, STD, LTD, Life and AD&D Insurance, Tax Free Commuter Benefits, 401k, and more.

OPT Industries is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

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