Engineer, Biopharma Medical Device (JP10473)
On-siteThousand Oaks, California, United States
Thousand Oaks, California, United StatesOn-siteContractBachelors Degree
ContractBachelors Degree
Job Summary
Support senior engineers on projects for prefilled syringes, authoring protocols, reports, and technical documentation while adhering to GMP standards. Conduct laboratory testing using force testers and vision systems, develop test methods, and lead system-level root cause investigations. Maintain design history files, generate design specifications, and coordinate design improvements with development partners. Work independently in cross-functional teams to assess manufacturing specifications and drive product launches.
Required Qualifications
- Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments
- Plans and conduct work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures and criteria
- Devises new approaches to problems encountered
- Accountability of maintaining technical records within design history file associated with assigned products
- Develop Test Method
- Generate and maintain design specification
- Protocol & report writing
- Prototyping
- DOE/SPC product optimization
- Design verification & validation
- FMEA
- Lead system level root cause investigation
- Coordinate design improvements with development partners
- Strategic 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
- Individual contributor with Leadership attributes to effectively represent device engineer within a large network/matrix organization
- Familiar with Quality System Regulation – 21CFR820
- Familiar with Risk Management – ISO 14971
- Familiar with EU Medical Device requirements – Council Directive 93/42/EEC
- BS in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology
- 3+ years of experience within the pharmaceutical/biotechnology industry
- Must have hands on Laboratory experience in a GLP Setting (Science or Engineering Lab)
- BS Degree in the field of Mechanical, Chemistry, Biomedical, Engineering, or any science degree
- Seeking a candidate with regulated work environment experience
- Must be able to lift up to 50 lbs for receipt and transferring of material
- Must have technical writing skills
Desired Qualifications
- Degree in the field of Mechanical or Biomedical
- Medical device industry experience
- Regulated work environment experience
- Background in developing and commercialization of medical devices
- Knowledge of manufacturing processes
- Strong understanding and experience in design controls
- Experience in failure investigation
- Experience initiating and bringing complex projects to conclusion
- Ability to work independently and dynamic cross functional teams
- Excellent written and verbal communication skill
- Fill-Finish experience
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