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3 Key Consulting, Inc. · 5 months ago

Engineer, Combination Devices Design/Development - (JP14307)

Thousand Oaks, CA., California

Full-time

Onsite

Entry Level

$36/hr - $41/hr

2+ years exp

3 Key Consulting is hiring an Associate Engineer for a consulting engagement with a leading global biopharmaceutical company. The candidate will support senior staff in device development, characterization, and verification of combination products, applying engineering principles to effectively complete projects.

AdviceCloud ComputingInformation TechnologyStaffing Agency

No H1B

U.S. Citizen Only

Responsibilities

Plan and author technical documentation, including test plans/protocols/reports and a variety of engineering assessments

Perform hands on testing of autoinjector devices, including the safe operation of test equipment and devices containing sharps (syringes)

Analyze and report data, along with any recommendations, to a variety of stakeholders

Provide technical input for mechanical problems to programs as needed

Plan and execute tolerance and robustness analysis of complex mechanical designs

Use project planning to monitor and track project deliverables to ensure accurate completion

Collaborate with cross-functional teams to ensure adequate sustainment and improvement of products throughout their lifecycle

As part of the team working on device platforms, ensure alignment of documentation to support variants and combination products

Qualification

Drug/device combination designLab testing executionTechnical writingMechanical design analysisQuality Management System knowledgeProject planningMS Office proficiencySolidworksMinitabJMPSmartsheetCommunication skillsCollaboration skillsProblem-solving skills

Required

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

B.S. in Engineering or Scientific Discipline

Effective Communicator (Oral/Written)

Technical Writing (Protocols, Reports, Technical Assessments, Presentations)

Strong written and oral communication skills

Able to execute lab test, which includes safe and proper operation of lab equipment

Experience in drug/device combination product design, and development

Preferred

Broad set of knowledge and expertise in contributing to complex, multi-disciplinary and cross-functional product development efforts

Experience in drug/device combination product design, and development

Background in development, commercialization, and lifecycle management of medical devices

Physical test method development, qualification, and validation

Experience executing lab tests, including safe and proper operation of lab equipment (Instron tensile tester, Keyence inspection equipment, manual and automated autoinjector testing, CT scanner etc.)

Experience conceptualizing, designing, and building test fixtures

Technical understanding of drawings including tolerance stacks and robustness analysis

Knowledge of Quality Management System, Quality Management Policy and applicable laws and regulations as they apply to this job type/position

Familiarity with the following standards: US Good Manufacturing Practices (21CFR820), Quality Management (ISO 13485), Risk Management (ISO 14971), EU Medical Device requirements (Council Directive 93/42/EEC), Needle Based Injection Systems (EN ISO 11608-1), and Medical Electrical Equipment (EN 60601)

Knowledge of dFMEA/pFMEA

Capable of working on multiple projects in a deadline driven environment

Strong oral and written communication skills, decision making, presentation, and organization skills

Ability to collaborate with other disciplines within the technical team such as, systems engineering, design engineering, human factors, MSAT, packaging engineering and other functions e.g., drug product, drug substance and product quality

Demonstrate ability to navigate ambiguity and provide a structured problem-solving approach

Track record of building or participating as a member of successful teams

Working knowledge of MS Office tools, Solidworks, Minitab or JMP and Smartsheet

Company

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.

Founded in 2009

Simi Valley, California, USA

51-200 employees