Senior Engineer - Drug Delivery Medical Device (JP5018)

Location: Thousand Oaks, CA
Date Posted: 11-21-2018
Job Title: Senior Engineer - Drug Delivery Medical Device (JP5018)
Location: Thousand Oaks, CA
Employment Type: Contract
Duration: 12 months with likely extensions
 
‚Äč3Key Consulting is looking for a Sr Engineer for a leading, international pharmaceutical company headquartered in Thousand Oaks, CA.
 
Job Summary: 
Support project teams in the development of drug delivery devices. Scope includes a wide range of devices such as needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems. The qualified candidate will support technical teams to ensure successful development of mechanical and electro-mechanical medical devices. The Senior Engineer will work closely with team members to develop detailed engineering specifications, device design & development, support verification, validation, design transfer, regulatory submissions, and commercialization of these devices and combination products. The role of the Senior Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development. 

Responsibilities: 
• Work cross-functionally with individuals and within project teams. 
• Create and assess product requirements to determine technical coverage and proper integration of 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 5 - 10 years current experience with engineering processes and procedures. 
• Participation in development projects from concept through the 510k and PMA approval process. 
• Strong background in engineering of electro-mechanical and disposable medical devices and combination products. 
• Ability to model and analyze mechanical systems, fluid flow, stress, assemblies, structures, linkages, heat transfer 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. 
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. 
• 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.
• Familiarity with the following standards: 
o 21CFR820 Quality System Regulation 
o ISO 14971 Risk Management 
o EU Medical Device requirements 
o Medical Devices Directive 93/42/EEC 
o Medical Electrical Equipment 
o EN 60601 

Top Must have Skill Sets:
1) BS in Mechanical Engineering and previous experience in a medical device, or similar industry, with 5 - 10 years current experience with engineering processes and procedures.
2) Strong background in engineering of electro-mechanical and disposable medical devices and combination products.
3) Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
 
Day-To-Day Responsibilities:
  • Working as a part of a cross-functional development team to support drug delivery device development and commercialization.
  • Drafting, reviewing, and approving protocols, reports, and other technical documentation following GDP.
  • performing device testing in a GLP environment.
  • Statistical analysis of data.
  • Generating and presenting technical information for the development team and management.
 
Why this position is open: We are looking for an Engineer to join the development team for a new combination product. We lost an EW a few weeks ago and looking to replace that person. This person will be doing protocol, report writing, data analysis some design work as well as assisting engineers in various projects.
 
Employee Value Proposition: This individual will be exposed to first hand experience developing a combination product and interfacing with a cross functional team.
 
Red Flags: No recent college graduates
 
Interview Process:
Phone (hiring manager only) and face to face (panel) interview with screened candidates.
 
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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