: Senior Engineer - Biotech Medical Device/Drug Product (JP7732)
Thousand Oaks, CA
: 6 months with likely extensions
Job posting date
working on site 25% of the time
3 Key Consulting is hiring a Project Manager
for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
- Work in 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 be key support member on 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 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.
- Execution of documentation and testing for new products in the process of launch
- Technical support and direction for cross functional team
- Participate in team meetings and reviews
- Report progress, achievements, and challenges in a timely manner
Top Must have Skill Sets:
- BS in Engineering or equivalent 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 standards: Quality System Regulation , 21CFR820 , 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.
- VERY IMPORTANT: Must be capable of working on multiple projects in a deadline driven environment.
- Bachelor’s Degree - Bioengineering, mechanical engineering, chemical engineering
Employee Value Proposition:
- Demonstrated knowledge of medical device and/or combination product regulations and standards (design Control, risk management) (5 years of experience)
- Experience working at least 2 years in medical device and/or combination product development or manufacturing (3-5 years of experience)
- Experience with test method qualification (3-5 years of experience)
gaining experience in combination product device, cross collaboration between medical devices and pharma departments, and growing your skill set.
Frequent job changes
No direct medical device/combination product experience
Phone interviews with 3 interviewers
We invite qualified candidates to send your resume to firstname.lastname@example.org. 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.