Engineer Senior, Drug Delivery Devices​/Development & Commercialization; JP

Engineer Senior, Drug Delivery Devices

We are recruiting an Engineer Senior, Drug Delivery Devices for a consulting engagement with our direct client, a leading global biotechnology company.

The Device Engineer will participate in the medical device/combination product design, development, and commercialization activities for drug delivery devices, focusing on prefilled syringes.

The ideal candidate will have a B.S. and a minimum of 3+ strong years of experience. 5 YOE is ideal. Nice to have: someone who has experience working on prefilled syringes or vials. Combination product experience. Regulatory experience.

• Pharma background.
• Physical testing experience
• Design controls experience

• Leading test procedure development and functional test execution
• Leading material inventory management for prefilled syringe programs, including material forecasting and material custody across multiple sites and functional groups.
• Authoring technical plans and reports
• Performing advanced statistical data analysis
• Supporting Leading technical assessments and root cause investigations as well as planning and delegation of sub-tasks to other team members.
• Transfer of information to manufacturing sites, engagement with suppliers
• Maintenance of Design History File content consistent with Good Documentation Practices
• Training junior staff on physical test methods, sample preparation protocols and procedures, and effective report writing.
• Reviewing primary data collected from peers in support for various design controls activities, including characterization and design verification.
• Supporting design transfer activities by leading cross-functional coordination of sample procurement and testing.
• Supporting the setting of specification limits for platform devices through human factors studies benchtop testing.

• Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
• Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments.
• Plans and conducts work requiring judgment in the independent evaluation, selection, and adaptation and modification of standard techniques/procedures/criteria, and devises new approaches to encountered challenges.
• Generates and maintains design specifications, protocol and report writing, prototyping, design of experiments/statistical process control product optimization, design verification & validation, FMEA, etc.
• System level root cause investigation; CAD/Solid Works proficiency; tolerance analysis; capability analysis.
• Coordinate and implement design improvements with development partners.
• Collaborate with scientists and engineers internally and externally to assess and develop appropriate design and manufacturing specifications.
• Accountability of maintaining technical records within product design history files.
• Individual contributor with leadership attributes to effectively represent device engineering within a large network/matrix organization.
• Working proficiency and familiarity with governing standards and regulations, including Quality System Regulation (21
  
  CFR
  820) and Risk Management (ISO 14971).

• Degree in the field of Mechanical or Biomedical Engineering, or related field
• Medical device industry and/or regulated work environment experience
• Excellent written and verbal communication skills
• Understanding and experience in:
• Development/commercialization of medical devices and knowledge of manufacturing processes
• Initiating and bringing complex projects to conclusion
• Ability to work independently and dynamic cross functional teams
• Design controls
• Failure investigation
• Applied statistics

• Poor communication skills
• Lack of hands on testing experience

Planned Project

One round of interviews.