System Engineer - drug/device combination (JP4206)

Location: Cambridge, MA
Date Posted: 05-04-2018
Job Title:  System Engineer - drug/device combination (JP4206)
Job Site:  Cambridge MA
Type: Contract
Duration: 12 Months with likely extension
Business Unit: Systems Engineering
 
3Key Consulting Inc. is recruiting for an Engineer with 2 - 3 years of experience for a global bio-pharmaceutical company.

Description:
Onsite M-F / core hours for this role would be 10-4, shifted towards afternoon since this team works closely with the thousand oaks team. Work environment is open/next Gen space.

Ideal Candidate- • Bachelor’s Degree in Engineering. 3+ years’ experience in drug/device combination product design and development. 3+ years’ experience in the Medical Device, Pharmaceutical, Biotechnology or other Healthcare-related field; 3+ years technical Project Management experience


Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions. Strong understanding and experience in design controls, failure investigation, initiating and bringing complex projects to conclusion. PM experience and experience with Microsoft Excel, Project and PowerPoint and statistical tools/analysis.

Job Summary
  • The engineer will be part of a sustaining engineering team working on commercial electro-mechanical delivery devices such as; fluid transfer devices, automatic pen injectors, and micro-infuser delivery pump systems.
  • The role of the Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support robust device development improvements.
  • Support system level root cause investigation, coordinate design improvements with development partners, strategic planning and execution of design changes and improvements.
  • 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.
  • Maintain technical records within design history file associated with assigned products.
  • Ability to work effectively in a fast paced, rapidly changing technology environment, and to manage technical activities around injection devices and combination products.
     
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
  • 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
     
MUST-HAVE Qualifications:
  • Project management experience
  • Experience with Microsoft Excel, Project and PowerPoint and statistical tools/analysis
  • BS degree in Engineering or similar field
  • Experience in Medical Device, Pharmaceutical, Biotechnology or other Healthcarerelated field

     
Preferred Qualifications
  • Bachelors Degree in Engineering
  • 3+ years experience in drug/device combination product design and development
  • 3+ years experience in the Medical Device, Pharmaceutical, Biotechnology or other Healthcare-related field;
  • 3+ years technical Project Management experience
  • Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
  • Ability to work effectively in a fast paced, rapidly changing technology environment, and to manage technical activities around injection devices and combination products.
  • Strong understanding and experience in design controls, failure investigation, initiating and bringing complex projects to conclusion
  • Ability to foster collaboration and work effectively on cross-functional teams
 
Employee Value Proposition:
Amgen is an amazing company to work for and is the best Bio-Tech company in the area. The team is phenomenal, best team to work with- Energetic, motivated team. The product working on is engaging, exciting, and successful in the market. In this role the work will be doing is so rewarding and this individual will be making a difference day 1 in this role.
 
Red Flags:
Little to no experience with Microsoft Excel, Project or PowerPoint No technical project management experience No technical degree/experience in Medical Device, Pharmaceutical, Biotechnology or other Healthcare-related field
 
Interview Process: Phone interview by hiring manager • In-person interview by up to 3 team members
 
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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