3 Key Consulting, Inc.

Engineer Senior, Drug Delivery Medical Device Biocompatibility (JP12000)

3 Key Consulting, Inc.  •  $45 - $50/hr  •  Thousand Oaks, CA (Onsite)  •  19 days ago
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Job Description

Job Title: Engineer Senior, Drug Delivery Medical Device (JP12000)
Location: Thousand Oaks, CA.  91320
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.


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.

3 Key Consulting, Inc.

About 3 Key Consulting, Inc.

3Key Consulting specializes in the rapid recruitment and placement of business and IT professional within the life sciences and healthcare industries. With 12 years of experience, 3Key has established a vast network of industry professionals and forged strong partnerships/alliances with key academic institutions across the country to continually develop our business professional and niche skill pipeline.

3KC offers a full suite of staffing solutions including PEO and compliance services. 3KC has several technology and industry domain practices including competencies in business intelligence, healthcare and life sciences.

People, process, and technology are 3 key areas of focus that we carefully examine individually and jointly, in order to deliver on our client's 3 key areas of focus - better, faster and cost effective BI and staffing solutions.

MISSION:

To create a better work experience for our customers, partners and employees through exceptional dedication and performance.

• We make hiring easier

• We build strong teams

• We bring about positive outcomes

VISION:

3 Key Consulting’s responsibility is to continually improve the manner and efficiency in which human resources and businesses are brought together to create value. Our vision is to put programs into action that improve market efficiencies while helping businesses and people be more productive.

Industry
Unknown
Company Size
1-10 employees
Headquarters
Simi Valley, CA
Year Founded
2009
Website
3keyconsulting.com
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