Job Description

Job Title: Engineer Senior, Combination Device Life Cycle Change Management (JP12255)
Location: Thousand Oaks, Ca.
Business Unit: Final Product Technologies Commercial Advancement
Employment Type: Contract
Duration: 1+ years with possible extensions or conversion to FTE
Rate $45 - $50/hour W2
Posting Date: 2/8/24
Note Office-based role supporting virtual teams via Webex and phone.

3 Key Consulting is recruiting an Engineer Senior, Drug Delivery Medical Devices for a consulting engagement with our direct client, a leading global biotechnology company.

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 product’s 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
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The technical professional we seek is a collaborative partner with these qualifications.

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

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

Top Must Have Skill Sets:

Medical device industry experience and regulated work environment experience
Medical Device Design Controls experience
Root cause analysis experience

Why is the Position Open?
Supplement additional workload on team

Red Flags:
Poor verbal communication skills

Interview Process:
Phone Interview followed by WebEx meeting/panel interview

We invite qualified candidates to send your resume to recruiting@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.

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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