Engineer Senior (JP8409)
Thousand Oaks, CA. (Partially onsite)
Final Product Technologies Commercial Advancement
18+ months (with likely extensions)
3 Key Consulting is hiring an Engineer Senior
for a consulting engagement with our direct client, a leading global biopharmaceutical company.
***Medical device/Combination product industry and electromechanical experience required***
The senior device engineer will partake in the design development and lifecycle management related activities for commercialized drug delivery devices. This includes technical operations support for contract manufacturing, failure investigation, leading and assessing design changes, developing test procedures, scale-up and global launch, supplier development, and continuous improvement.
Scope includes mechanical and electro-mechanical delivery devices, such as: fluid transfer devices, automatic pen injectors, reusable automatic injectors, or micro-infuser delivery pump systems. The qualified candidate will be part of a sustaining device engineering team that ensures design history files of these systems are maintained. The engineer will participate in multi-functional teams, leading device design activities such as developing product improvements, supporting new development project teams, analytical failure analysis and implementing design solutions, assessment of proposed changes, product launches, and defending inspection and follow through of commitments.
Why is the Position Open?
- 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
- EU Medical Device requirements
- Council Directive 93/42/EEC o Medical Electrical Equipment
- EN 60601 - Small scale device assembly experience.
- Strong problem solving, risk assessment, and risk management skills.
- VERY IMPORTANT: Must be capable of working on multiple projects in a deadline driven environment.
Supplement additional workload on team
Top Must-Have Skill Sets:
Day to Day Responsibilities:
- Ability to work on multiple projects against defined schedules (project management experience)
- Experience in medical device manufacturing environments
- Resume is well organized and clear demonstrating excellent written communication skills
- Apply all conventional aspects of the subject matter, functional area, and their assignments; plans and conducts work requiring judgment in the independent evaluation, selection, and meaningful adaptation and modification of standard engineering techniques, procedures and criteria and devises new approaches to problems encountered.
- Accountable for maintaining technical records within design history file associated with assigned products.
- Support system level design, development, and V&V work for commercial lifecycle management changes or in support of new project development
- Develop test methods, generate and maintain design specifications, protocol & report writing, prototyping, DOE/SPC product optimization, design verification & validation, FMEA, etc.
- Lead system level root cause investigation, coordinate design improvements with development partners, tactical planning and execution of design changes and improvements.
- Works with Scientists and Engineers internally and externally to assess and develop appropriate design and manufacturing specifications
- Performs as an individual contributor with leadership attributes to optimally represent device engineering within a large network/matrix organization
Master’s Degree and 2 years of Engineering and/or Operations experience within a cGMP manufacturing environment/ OR within a biotech or medical device manufacturing environment
Bachelor’s Degree and 4 years of Engineering and/or Operations experience within a cGMP manufacturing environment/ OR within a biotech or medical device manufacturing environment
Associate’s degree and 10 years of Engineering and/or Operations experience within a cGMP manufacturing environment/ OR within a biotech or medical device manufacturing environment
High school diploma/GED and 12 years of Engineering and/or Operations experience within a cGMP manufacturing environment/ OR within a biotech or medical device manufacturing environment
Employee Value Proposition:
- Medical device industry experience and regulated work environment experience
- A background in development and commercialization of medical devices and knowledge of manufacturing processes
- Systems Engineering design experience and thinking, driving user needs to design requirements to verified and validated final product outputs
- Strong understanding and experience in design controls, failure investigation, initiating and bringing complex projects to conclusion
- Familiar with the following standards and regulations: Quality System Regulation – 21CFR820, Risk Management – ISO 14971, EU Medical Device requirements – Council Directive 93/42/EEC
- Ability to work independently and across functional teams
- Excellent (technical) written and verbal communication
Works on the only client-owned electro-mechanical auto injector. We also work with suppliers all around the world.
- No medical device experience
- History of frequent job changes
- Unexplained gaps in employment
- No recent college graduates
- No project management experience
- No manufacturing experience
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.