Senior Mechanical Engineer

3 days ago


Thousand Oaks, California, United States ACL Digital Full time
About the Role

We are seeking a highly skilled Senior Mechanical Engineer to join our team at ACL Digital. As a key member of our engineering team, you will be responsible for performing Sustaining Engineering activities of combination products with electromechanical delivery systems.

Key Responsibilities
  • Complete product and manufacturing process changes, including documentation and risk file updates to ensure there is no adverse impact to the patient/user and product design integrity is maintained.
  • Implement change projects according to internal procedures, supervise progress, and communicate status to group leadership.
  • Communicate with Engineering, Manufacturing, Regulatory, and Quality colleagues to ensure seamless collaboration and effective problem-solving.
  • Establish experimental protocols, conduct experiments, and analyze results to drive product development and improvement.
  • Support technical execution of Design History File (DHF) updates and ensure product conformity to current relevant international standards.
  • Establish and maintain relationships with manufacturing site colleagues to foster a culture of collaboration and continuous improvement.
  • Support Manufacturing and Quality Assurance in the disposition of Non-Conforming Reports and the qualification of material/processes changes.
  • Establish and review specifications/requirements for components, products, and processes to ensure compliance with regulatory requirements.
  • Support CAPA investigations and ensure root cause analysis is conducted to prevent future occurrences.
Requirements
  • Bachelor's degree in Engineering, Science, or other technical degree.
  • 1-3 years of experience with Medical Device or Combination Products Design Controls, Production, Sustaining Engineering, or Quality role.
  • Proven knowledge and experience in Device Design Control, Risk Management, Medical Devices, and Combination Products.
  • Experience analyzing patient/user impact and understanding of 21 CFR Part 820, ISO 13485, and ISO 14971.
  • Critical thinking, problem-solving skills, and ability to work independently as well as a member of a team in a fast-paced environment.
  • Working knowledge of statistical methods for data analysis and familiarity with microcontroller-based firmware, software verification, and circuit design.
  • Ability to converse technically with mechanical, electronic, software, clinical, regulatory, and quality engineering fields.
Preferred Qualifications
  • Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience.
  • Medical device industry experience and regulated work environment experience.
  • Medical Device Design Controls experience.
  • Root cause analysis experience.


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