Medical Device Engineer
Duration: 12 months - extension possible
Location: S. San Francisco
**Experience in Drug-device combination product and drug delivery device design and development required**
The Device Development Group sits in the BioPharmaceutical R&D organization and has offices in Gaithersburg, MD and South San Francisco, CA. The group is responsible for design, development, healthcare authority approval and ultimately launch of drug/device combination products. The product portfolio is mainly focused on subcutaneous drug delivery system, and also have several new Technology Development projects in other related areas.
Main Duties & Responsibilities:
- High functioning technical and collaborative member of cross functional CMC and device development teams to meet program deliverables
- Applies engineering principles with minimal oversight in the design and development of robust devices and drug/device combination products
- Able to independently solve complex problems using tools such as: engineering modelling and simulation tools, design and prototyping tools, statistical analysis, benchtop experiments and analysis, usability engineering tools, design for manufacturability/assembly techniques and design for six sigma.
- Strong working knowledge and experience with regulations and standards such as design controls, risk management, human factors and industry standards specific to an individual’s discipline
- Identifies and effectively communicates potential design/process problems, analyses problems following best practices, provides practical solutions and manages the consequences of any failures
- Represents the Function internally as well as externally with CMOs and development partners.
Education & Experience Requirements:
Bachelor’s degree in Mechanical or Biochemical Engineering, or related discipline with 3-5 years of service in engineering related role. In lieu of degree, minimum 8 years of service in a relevant engineering role.
- Experience and thorough understanding of medical device development
- Experience in development of drug/device combination products for subcutaneous delivery
- Demonstrated experience of product characterization, design controls and risk management
- Extensive experience of working in a cross functional product development environment
- Excellent communication skills (both written and oral) to summarize development work, critical conclusions and its relevance to the bigger picture
- Demonstrated experience in one or several of the following areas: new technology development, process development, combination product development, human factors, test methods development, device/process characterization, design controls, risk management
- Technical leadership of cross-functional development teams
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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