3 Key Consulting, Inc.

Engineer, Electromechanical Medical Device - Hybrid (JP13404)

3 Key Consulting, Inc.  •  $36/hr  •  Thousand Oaks, CA (Remote)  •  13 days ago
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Job Description

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)



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  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.
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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