Engineer - Medical Device / Project Management (JP4565)

Location: Thousand Oaks, CA
Date Posted: 08-01-2018
Title: Engineer - Medical Device / Project Management (JP4565)
Location: Thousand Oaks, CA.
Employment Type: Contract
Duration: 6 months  with likely extensions
Business Unit: Mechanical Engineering
 
‚Äč3Key Consulting is looking for an Engineer for a leading, international pharmaceutical company headquartered in Thousand Oaks, CA
 
JOB SUMMARY:
Ideal Candidate- 5+ years of experience in the Medical Device, Pharmaceutical, Biotechnology or other Healthcare related field. Graduate degree with 2+ years of Project Management experience. Ability to work effectively in a fast paced, rapidly changing technology environment, and to manage technical activities around injection devices and combination products. 

Manager is looking for someone who has a mechanical engineering or bioengineering (medical device) background (recent grad ok) and preferably someone who is HIGHLY organized with a project management skillset. A person who performs well in a face-paced environment is essential. 

The Device Engineer will support the autoinjector platform project team as both a project manager and engineer. Scope includes improving the development process of automatic pen injectors. The qualified candidate will support the platform technical teams to ensure successful completion of project tasks. 

The Engineer will work closely with team members to develop and maintain project schedules, track deliverables, develop detailed engineering requirements documents, support verification, validation, and design characterization. The role of the Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support robust device development improvements. 

Responsibilities: 
-Manage the project schedule with a focus on effective planning, coordination of activities, and communication 
-Manage project communication to key stakeholders 
-Facilitate and driving decision making using DAI principles 
-Plan and facilitating of functional and cross-functional management reviews 
-Establish and managing collaboration and team sites (e.g. SharePoint) 
-Facilitate and incorporating lessons learned, best practices, etc. 
-Support business process improvements 
-Identify and manage risks 
-Work cross-functionally with individuals and within project teams 
-Create and assess product requirements to determine technical coverage and proper integration different subsystems 
-Perform design analyses and assessments 
-Execute design characterization and design verification testing 
-Develop, execute, and review design documents, specifications, development plans, characterization 
plans, verification plans, reports, and other related product development documents for assigned 
projects 
-Provide technical assistance to projects 

Skills: 
BS in Mechanical Engineering and previous experience in a medical device, or similar industry, with 2 
- 6 years current experience with engineering processes and procedures. 
Experience in technical project management 
Strong background in engineering of disposable medical devices. 
Ability to model and analyze mechanical systems, assemblies, structures, linkages, and other mechanical engineering specialties. 
Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA. 
Product design/development (design control) from concept to post product launch for Europe (EMEA/CE 
Mark) & US (FDA/PMA/510k) submissions. 
Experience in drug/device combination product design and development. 

Familiarity with the following standards: 
21CFR820 Quality System Regulation 
ISO 14971 Risk Management 
EU Medical Device requirements 
Medical Devices Directive 93/42/EEC 
Medical Electrical Equipment 
EN 60601 

Strong problem solving, risk assessment, and risk management skills. 
Must be capable of working on multiple projects in a deadline driven environment. 
Plastic part design experience is a plus. 

Preferred Qualifications: 
5+ years of experience in the Medical Device, Pharmaceutical, Biotechnology or other Healthcare- 
related field; 
Graduate degree with 2+ years of Project Management experience 
Ability to work effectively in a fast paced, rapidly changing technology environment, and to manage technical activities around injection devices and combination products. 
Ability to foster collaboration and work effectively on cross-functional teams
 
TOP MUST-HAVE SKILL SETS:
1. Project management experience
2. Medical device development experience
3. Knowledge and experience with Good Documentation Practices
4. A person who performs well in a face-paced environment is essential.
 
DAY-TO-DAY RESPONSIBILITIES:
Manage project schedules and deliverables. Moderate and schedule meetings. Prepare and distribute meeting agendas and minutes Follow-up with team members on deliverables, action items, and status. Provide status updates, Prepare and execute characterization or verification testing including authoring of protocols and reports Author design control documentation
 
EMPLOYEE VALUE PROPOSITION: This is a new project in the device platform team and business process improvement project within engineering department.
 
RED FLAGS: Little to no experience with Microsoft Project or Powerpoint No engineering development experience No technical project management experience
 
INTERVIEW PROCESS: 1. Phone interview by hiring manager 2. In-person interview by up to 5 team members
 
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We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.**No Third-party Vendors Please**
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Regards,
 
3KC Talent Acquisition Team
 
 
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