Engineer Senior, Drug Device Technology (JP7546)
CA. (Remote then onsite pending lifting of COVID restrictions)
Device Strategy Technology Assessment
12 months with likely extensions or conversion to FTE
3 Key Consulting is hiring a Senior Engineer
for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Candidate will be working remote until the site reopens
Min Bachelors Degree in Engineering
5+ years of experience within Pharma, Biotech, Med Device
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.
- 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.
Top Must-Have Skill Sets:
- BS in Engineering and previous experience in a medical device industry
- 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
- 21CFR820 o Risk Management
- ISO 14971 o EU Medical Device requirements
- Council Directive 93/42/EEC o Medical Electrical Equipment
- EN 60601 - 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
Day to Day Responsibilities:
- design controls
- mechanical testing
- drug delivery experience
- risk base process
- presentation skills
Employee Value Proposition:
- 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
Opportunity to gain exposure to design control and design transfers within a quality regulated environment. Fast pace & high exposure.
Less than 5 years of experience, jumpy job history
3-4 interviews with hiring manager and key stakeholders
virtual: phone/video based only
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 welcome to also welcome to share this opportunity with anyone you think might be interested in applying for this role.