Job Title: Senior Engineer – Drug/device combination product (JP9339) Location: Thousand Oaks, CA. Employment Type: Contract Business Unit: FPT Development Product Engineering Duration: 1+ years (with likely extensions and/or conversion to permanent) Posting Date: 11/3/21
3 Key Consulting is hiring a Senior Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description: Lead 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 lead technical teams to ensure successful device development of these 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, and regulatory submissions of these devices. 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.
Top Must Have Skills:
Drug delivery experience.
Risk base process.
Day to Day Responsibilities:
Author device documentation to support development, planning, verification, validation, and transfer.
Author test protocols and execute mechanical testing of drug delivery devices.
Presentation and communication skills (within program teams).
Execute and deliver within regulated development processes.
Proactively maintains close communication with technical leads.
Work cross-functionally with individuals and project teams in Marketing, Operations, and Development.
Create and assess product requirements to determine technical coverage and proper integration different subsystems.
Create and execute to project plans and schedules.
Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects.
Provide deep technical assistance for junior engineers.
BS in Engineering and previous experience in a medical device industry.
10 years current experience with engineering processes and procedures.
Led projects from development through the 510k and PMA approval process.
Strong background in engineering and commercialization of electro-mechanical medical devices.
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.
Familiar with the following standards:
Quality System Regulation.
ISO 14971 o EU Medical Device requirements
Council Directive 93/42/EEC
Medical Electrical Equipment
Small scale device assembly experience.
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.
VERY IMPORTANT NOTE: Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background need apply and will be considered.
Red Flags: Less than 5 years of experience, jumpy job history, lack of enthusiasm and not self-motivated.
Video Skype Panel Interview
We invite qualified candidates to send your resume to email@example.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.