Job Details

Job Title: Engineer, Electromechanical Medical Device - Hybrid (JP13404)
Location: Thousand Oaks, Ca. (2-3 times/month onsite)
Business Unit: Electromechanical Platform
Employment Type: Contract
Duration: 3 years with likely conversion to perm
Rate: $36-41/hours W2 with benefits
Posting Date: 11/21/2024
Target Start Date: 01/13/2025

3 Key Consulting is hiring! We are recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Ideal Candidate:
Self-sufficient, team-oriented candidate with strong communication and technical documentation skills. Ideal candidates should have electromechanical or engineering experience, proficiency in complaint management systems, and knowledge of CAPA processes and GDP. Familiarity with Excel for data analysis. Stability and a bachelor's degree with a few years of relevant experience are preferred.

Medical device industry experience and regulated work environment experience.
Strong understanding and experience in design controls, failure investigation (leading an investigation)

Job Description:
Perform Sustaining Engineering activities of combination products with electromechanical delivery systems. Such activities support the identification, review, assessment, and resolution of deficiencies throughout the product's life cycle. Responsible for product life cycle change management and ensures design controls are documented in accordance with internal procedures. Support multi-functional assessment of complaint records

Top Must Have Skill Sets:

• Ability to clearly communicate with diverse teams, including Engineering, Manufacturing, Regulatory, and Quality colleagues.
• Strong written skills for documenting changes, updates to risk files, and communication with leadership.
• Multidisciplinary assessment of complaints and problem-solving.

Day to Day 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

Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Red Flags:

• Difficulty clearly communicating with cross-functional teams or documenting changes effectively.
• Lack of precision or detail in written documentation
• Inability to convey project progress or results to leadership, leading to misunderstandings or misalignment

Interview Process:
Screening interview with the hiring manager followed by team interview.

We invite qualified candidates to send your resume to ...@3keyconsulting.com . If you decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Regards,

3KC Talent Acquisition Team