Mechanical Engineer

2 days ago

Thousand Oaks, California, United States ACL Digital Full time
Job Title – Senior Engineer

Location – Thousand Oaks, CA – 91320 Onsite

Duration: 12 Months

Description:

ACL Digital is seeking a highly skilled Senior Engineer to join our team. As a Senior Engineer, you will play a critical role in the development and maintenance of our electromechanical 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
  • Establish experimental protocols, conduct experiments, analyze results
  • Support technical execution of Design History File (DHF) updates
  • Establish and maintain relationships with manufacturing site colleagues
  • 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
  • Support CAPA investigations
  • Ensures product conforms to current relevant international standards
  • Support multi-functional assessment of complaint record

Preferred Qualifications:

  • Bachelors 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
  • Understanding and practical knowledge of 21 CFR Part 820, ISO 13485 and ISO 14971 and relevant industry standards
  • Critical thinking, and problem-solving skills
  • An 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
  • Familiar with microcontroller-based firmware, software verification (unit, static, dynamic analysis)
  • Familiar with circuit design, analysis, troubleshooting, and testing, PCB/PCA assembly and fabrication
  • Ability to converse technically with mechanical, electronic, software, clinical, regulatory, and quality engineering fields
  • The position requires excellent organizational, technical problem solving and communication skills (written and verbal) and the ability to lead external teams

Basic 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

Top 3 Must Have Skill Sets:

  • Medical device industry experience and regulated work environment experience
  • Medical Device Design Controls experience
  • Root cause analysis experience

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