Engineer Senior, Drug Delivery Medical Device Biocompatibility - REMOTE PST (JP12000)

Job Title: Engineer Senior, Drug Delivery Medical Device Biocompatibility – REMOTE PST (JP12000)
Location: Thousand Oaks, CA.  91320 (100% REMOTE PST)
Business Unit: Design Control
Employment Type:  Contract
Duration: 1+ years (with possible extensions)
Rate: $45 - $50/hour W2
Posting Date: 11/30/2023
Notes: Only qualified candidates need apply. 
3 Key Consulting is recruiting an Engineer Senior, Medical Device Biocompatibility for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description:
The ideal candidate for this role is a highly qualified professional with a Bachelor's degree in Science or Engineering and a minimum of 5 years of experience in the Medical Device industry. They possess a robust understanding of ISO 10993 biocompatibility standards, particularly parts 3, 4, 6, 7, 11, and 18, along with expertise in drug/device combination product design and development. With a solid grasp of Medical Device Regulations such as 21CRF820 and ISO 13485, excels in assessing and ensuring regulatory compliance. Excellent communication skills, both written and verbal, enable effective coordination with diverse stakeholders, and they exhibit strong problem-solving abilities. A team player with meticulous attention to detail, thrives in a deadline-driven environment, managing multiple projects while maintaining cross-functional alignment and presenting detailed information to governance bodies.
Top Must Have Skill Sets:
1) Expertise in ISO 10993 biocompatibility standard, especially parts 3,4,6,7,11, and 18.
2) Familiarity with Medical Device Regulations (21CFR820 and ISO 13485),
3) Good communication skills to coordinate standard assessments.
Day to Day Responsibilities:
• Detailed technical assessment of new/revised external requirements.
• Coordinate the assessment of changes to external requirements in collaboration with other Subject Matter Experts.
• Conduct document management system search for impacted records and disposition documents accordingly.
• Communicate outcome of technical decisions to all impacted platform and product teams.
• Coordinate with all impacted product teams to complete integration of requirement or justify no action and document it in Product Impact Assessment
• Maintain cross-functional, platform and product alignment.
• Present summary of details and advice to Product External Requirement governance for a decision on Amgen’s position regarding a standard’s impact.
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
- BS in Science or Engineering and previous experience in a Medical Device industry - 5 years current Medical Device industry experience .
- Strong Expertise in ISO 10993 biocompatibility standard, especially parts 3,4,6,7,11, and 18
- Experience in drug/device combination product design and development - Familiar with with Medical Device Regulations (21CRF820 and ISO 13485).
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
- Strong Problem solving and communication skills.
- Must be capable of working on multiple projects in a deadline driven environment.
Red Flags:
Not employed for more than 6 months.
Interview Process:
Phone / Webex interview
We invite qualified candidates to send your resume to resumes@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.