Job Title:Engineer Electromechanical Medical Device Hybrid (JP13404 Location:Thousand Oaks Ca. 23 times/month onsite) Business Unit:Electromechanical Platform Employment Type: Contract Duration:3 years with likely conversion to perm Rate: $3641/hours W2 with benefits Posting Date:11/21/2024 Target Start Date:01/13/2025
3 Key Consulting is hiring! We are recruiting anEngineerfor a consulting engagement with our direct client a leading global biotechnology company.
Ideal Candidate: Selfsufficient teamoriented 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 bachelors 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 products life cycle. Responsible for product life cycle change management and ensures design controls are documented in accordance with internal procedures. Support multifunctional 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 problemsolving.
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
Support technical of Design History File (DHF) updates
Establish and maintain relationships with manufacturing site colleagues
Support Manufacturing and Quality Assurance in the disposition of NonConforming 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 multifunctional 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 crossfunctional 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.
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