Mechanical Engineer - Thousand Oaks, United States - ACL Digital

ACL Digital Thousand Oaks, United States

4 weeks ago

Description

Job Title Senior Engineer

Location Thousand Oaks, CA 91320 Onsite

Duration: 12 Months

Pay Rate: $50. 00

Description:

ONSITE USTO

Standard business hours

What you will do

Lets do this. Lets change the world. In this vital role you will perform Sustaining Engineering activities of combination products with electromechanical delivery systems. Such activities support the identification, review, assessment, and resolution of deficiencies throughout the products life cycle. Responsible for product life cycle change management and ensures design controls are documented in accordance with internal procedures.

Office-based role supporting virtual teams via Webex and phone.

Flexibility required when working with global colleagues in various time zones.

Must be able to travel up to 5% - Would be to Phoeniz AZ if required

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

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

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

Day to Day Responsibilities: