: Sr Engineer (JP5173)
: Thousand Oaks, CA
: 12 months with likely extensions
3Key Consulting is looking for an Sr Engineer for a leading, international pharmaceutical company headquartered in Thousand Oaks, CA.
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.
• 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.
• 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.
• 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
• 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.
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.
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.
Employee Value Proposition
: This individual will be exposed to first hand experience developing a combination product and interfacing with a cross functional team.
: No recent college graduates
Phone (hiring manager only) and face to face (panel) interview with screened candidates.
We invite qualified candidates to send your resume to email@example.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
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