About OPT Industries

The global ecosystem of manufacturing is experiencing fundamental change. Additive manufacturing is a key technology to shorten supply chains and create superior products in medical, cosmetic, textile, and packaging industries, as well as and many other domains.

OPT Industries (http://optindustries.com) is a rapidly growing, venture-backed MIT spinoff company that focuses on building the next generation of additive manufacturing technology. We design and manufacture custom textile materials and products - everything from medical devices to luxury fashion. As we continue to grow and expand our operation, we are looking for manufacturing assistants to join our production team.


Job Description

This position supports the execution of routine testing as part of OPT Industries' manufacturing operation while strictly adhering to site work instructions, Federal Regulations, cGMP, and OPT Industries policies and procedures. This position requires the individual to perform product testing and complete required documentation as scheduled to support production, test method validation, and New Product Development. Follows manufacturing procedures, quality & EHS regulations, and company SOPs to ensure product specification levels are met.


Principal Responsibilities

  • Be accountable for maintaining a working knowledge of basic cGMP & ISO 9001 / 13485 requirements to ensure adherence to compliance policies and regulations.
  • Proactively apply 5S principles by maintaining a clean and safe work environment, take necessary action to eliminate safety hazards, and communicate to others any observed unsafe behaviors.
  • Accurately complete documentation in SOP’s, logbooks and other GMP documents.
  • Work independently and as a part of an additive manufacturing team.
  • Perform testing, inspection, and measurement of products at various stages of the new product development process along with production process in accordance with documented procedures.
  • Prepare detailed reports on the results of testing, evaluation and analysis.
  • Diagnose and verify product originally not meeting specifications.
  • Manage the calibration inspection, measuring and test equipment, of minimal to moderate complexity as prescribed by manufacturing specifications.
  • Record results of calibrations in calibration software.
  • Incoming inspection working with calipers, tensile and compression testers, vision measurement systems, and force gages.
  • Execute test method validations including gage R&R studies.


Additional Responsibilities

  • Offer suggestions and follow up on process improvements related to safety, compliance, cost, yield, and productivity.
  • Carry out duties in compliance with all state and federal regulations and guidelines, including FDA, EPA, and OSHA.
  • Adhere to the Safety Code of Conduct & EHS policies and attend all required EHS training.
  • Attend departmental and other scheduled meetings.
  • Practice good interpersonal and communication skills.
  • Demonstrate positive, collaborative approach in the day to day execution of procedures.
  • Learn new skills, procedures and processes as assigned by management and continue to develop expertise.
  • Responsible for audit preparation and participation.


Qualifications

  • 1-3 years manufacturing equipment experience or equivalent industry experience is required.
  • Incoming quality experience within regulated industry.
  • GD&T (Geometric Dimensioning, & Tolerancing) working experience / training.
  • High School Diploma/GED with 2-3 years in cGMP manufacturing environment, or Associate degree with 0-2 years of experience in GMP manufacturing
  • Proficiency in computerized systems.
  • Experience working in a controlled environment area GMP and ISO standards.
  • Ability to handle delicate materials and do precision manual alignments.
  • Ability to accurately and thoroughly document work on printed documents and computer databases.
  • Fluent in English.


Benefits

OPT Industries provides the following benefits to all full-time employees:

Medical, Dental, Vision, 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.