Engineer Senior – Biotech Automated Medical Devices and Mechanical Systems (JP8432)
Thousand Oaks, CA. (25% onsite &b 75% remote))
PFS And Lyo Kit Platforms
1+ years (with likely extensions)
3 Key Consulting is hiring a Senior Engineer
for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Must have skills:
- Mechanical engineering
- Pharma / design control experience
- Primary container knowledge
- EMA / FDA regulatory guidance
Support teams in the development and/or lifecycle management of drug delivery devices. Scope includes a wide range of devices, such as; prefilled syringes, needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems. The priority for this role lays with the prefilled syringe systems. 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 and change management.
- 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 technical assistance for junior engineers.
Day to Day Responsibilities:
- BS in Engineering and previous experience in a medical device industry
- 5 years current experience with engineering processes and procedures.
- Led projects from development through the 510k and PMA approval process.
- Strong background in engineering, manufacturing and commercialization of medical devices.
- Experience with primary containers, 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 Regulation21CFR820
- Risk Management ISO 14971
- EU Medical Device requirements Council Directive 93/42/EEC
- 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.
Employee Value Proposition:
- Lead/support verification efforts including documentation and testing
- support regulatory filings / documentation, EU MDR readiness
- Lead/support RCAs for market / manufacturing complaints
more experience to verification testing , test report, tech assessments with large biotech
Not local to Thousand Oaks - need to be able to go onsite for lab access.
Phone/Video Panel Interview.
We invite qualified candidates to send your resume to firstname.lastname@example.org
. 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 share this opportunity with anyone you think might be interested in applying for this role.