Jan 13, 2022

Manufacturing Engineer

$90,000 - $120,000 yearly
  • Desktop Health
  • Charlestown, Boston, MA, USA
Full time Manufacturing

Job Description

Desktop Health, based in Newport Beach, California, is leveraging additive manufacturing and advanced materials to personalize patient care. Desktop Health is vertically integrated to develop, manufacture and commercialize applications across a range of healthcare specialties. The company is rapidly focused on leveraging its bio printing capabilities across several key specialties.

The Manufacturing Engineer will work with an interdisciplinary team to develop the commercial manufacturing process and scale-up of novel 3D printed tympanic membrane grafts (PhonoGraft) and other tissue grafts as part of the Desktop Health team. We are a small team located in Boston, MA (parking available), working to improve the lives of people with tympanic membrane perforations and other medical conditions. The candidate will work under the direct supervision of the Vice President of Biomaterials and Innovation, with support from a Mechanical Engineer, a Material Engineer, and Research Technicians.

Primary Responsibilities include:

  • Assists in the Failure Mode and Effects Analysis (FMEA) and control plans for Process FMEAs
  • Lead the manufacturing of medical devices with an EnvisionTEC 3D-Bioplotter
  • Lead the setup of a medical grade manufacturing environment
  • Supervise an Operator who will perform day-to-day manufacturing work
  • Lead the establishment of a Quality Management System (QMS)
  • Lead the development, review and approval of process and equipment validation and qualifications (IQ, OQ, PQ) while assuring appropriate testing and statistical methods are utilized
  • Assist in design control activities, including the assembly of a design history file (DHF) and a device master record (DMR)
  • Review and approve design control documentation
  • Manage Quality Control activities, SOP updates, and process improvement discussions and investigations from a Quality Assurance standpoint
  • Assist in document control and management
  • Assist in the design of protocols for the sterilization and packaging of medical devices
  • Collaborate with Design and Development team on 3D printing processes for medical devices
  • Prepare and author SOPs related to manufacturing of medical devices
  • Interface with regulatory and manufacturing consultants to determine best practice

Education & Experience

  • Bachelor’s degree in Manufacturing Engineering, Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Biology, Physics, Mathematics, Computer Science, or related field
  • 3 - 8 years of experience working in the medical device industry
  • Experience working with a Quality Management System (QMS)
  • In depth familiarity with FDA, ISO, MDD, and medical device industry quality requirements associated with product design & development, product risk management, and design control

Knowledge/Skills/Abilities

  • Familiarity working with a QMS software tool such as Greenlight Guru or Propel
  • Familiarity with FDA’s 21 CFR Part 820 and ISO 13485
  • Knowledge of Good Manufacturing Practices (GMP)
  • Knowledge of Six Sigma and Lean Manufacturing practices
  • The candidate should be highly motivated toward translational research, have a strong work ethic, and take initiative to achieve project goals with minimal oversight
  • Skilled in statistical methods and design of experiments
  • Professional written and oral communication skills
  • Experience and comfort working with 3D printers and cleanroom environments is a bonus
  • Familiar with Keyence 3D Surface Profiler System is a bonus

Desktop Health is a division of Desktop Metal. At Desktop Metal, innovation is at the core of our DNA. And we believe ground-breaking discoveries are born from diverse teams with unique backgrounds and experiences. We are committed to employing a diverse workforce with equal employment opportunities regardless of race, color, religion, sex, national origin, age, sexual orientation, gender identity, gender expression, age, marital status, veteran status, or disability.


Apply Now