: Senior Engineer (JP8211)
Thousand Oaks, CA 91320
Final Product Technologies Commercial Advancement
: 12 months with likely extensions
Job posting date
3 Key Consulting is hiring a Senior Engineer for a consulting engagement with our direct client, a leading global bio-pharmaceutical 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.
- VERY IMPORTANT: Must be capable of working on multiple projects in a deadline driven environment.
- 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 –
- Small scale device assembly experience.
- Strong problem solving, risk assessment, and risk management skills.
- Familiar with the following standards:
- Quality System Regulation
- Risk Management
- ISO 14971
- EU Medical Device requirements
- Council Directive 93/42/EEC
- Medical Electrical Equipment
- EN 60601
- Doctorate Degree Or 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.
- OR 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.
- Or 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.
- Or 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.
- Master’s degree in biomedical/mechanical/electrical or related Engineering field and 5+ years of related engineering experience.
Top Must have Skill Sets:
- Medical device industry experience and regulated work environment experience.
- A background in development and commercialization of medical devices and knowled.ge 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
- Ability to work on multiple projects against defined schedules.
- Experience in medical device manufacturing environments.
- Resume is well organized and clear demonstrating excellent written communication skills.
Employee Value Proposition:
- 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.
Works on the only Amgen owned electromechanical auto injector. We also work with suppliers all around the world.
1. no medical device experience
2. history of frequent job changes
3. unexplained gaps in employment
4. No recent college graduates.
1. webex call with hiring manager
2. webex with 3-4 team members for top candidates.
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.