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Staff Manufacturing Engineer

4 months ago

Boston, United States Activ Surgical Full time


Activ Surgical is seeking a talented and driven Manufacturing Engineer to join our dynamic team. As a Manufacturing Engineer, you will play a crucial role in the design, development, and optimization of manufacturing processes to support the production of our innovative medical devices. You will collaborate closely with cross-functional teams to drive efficiency, quality, and scalability in manufacturing operations, contributing directly to the success of our mission to transform surgical care.


Responsibilities:

  1. Design, develop, and optimize manufacturing processes for the production of medical devices, ensuring efficiency, quality, and compliance with regulatory standards.
  2. Conduct process validations, including IQ/OQ/PQ, to ensure manufacturing processes meet regulatory requirements and product specifications.
  3. Identify and implement process improvements and cost-reduction initiatives to enhance efficiency and profitability.
  4. Develop and maintain manufacturing documentation, including work instructions, standard operating procedures (SOPs), and manufacturing batch records.
  5. Provide technical support to manufacturing operations, troubleshooting issues and implementing corrective and preventive actions (CAPAs) as needed.
  6. Collaborate with R&D, engineering, and product development teams to transfer new products from development to manufacturing, providing input on design for manufacturability (DFM) and assembly (DFA).
  7. Stay abreast of industry trends, best practices, and emerging technologies in manufacturing engineering, and leverage this knowledge to drive innovation and improvement in manufacturing processes.
  8. Ensure compliance with regulatory requirements, including FDA QSR, ISO standards, and other relevant regulations.


Qualifications:

  • Bachelor's degree in mechanical engineering, industrial engineering, or a related field.
  • 7-10 years of experience in manufacturing engineering or a similar role, preferably within the medical device industry. We will consider internship experience.
  • Strong understanding of manufacturing processes, including machining, assembly, and quality control methods.
  • Experience with process validation (IQ/OQ/PQ) and statistical analysis.


Join Activ Surgical and be part of a passionate team dedicated to driving innovation and excellence in surgical care. If you are a results-driven manufacturing engineer with a passion for technology and continuous improvement, we encourage you to apply for this exciting opportunity.