Previous Job
Previous
Engineer - AFP
Ref No.: 18-01259
Location: Cambridge, Massachusetts
Start Date / End Date: 06/01/2018 to 05/31/2019
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 Healthcare-related
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