Sr. Medical Device Engineer - new job in South San Francisco, US

Sr. Medical Device Engineer
  • $75 - $90 per Hour
  • Temporary
  • South San Francisco CA, US South San Francisco SAN MATEO US 94080
Job Ref: JO000132414
Sector: Clinical
Sub-sector: Quality
Date Added: 02 August 2022

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.

Required Skills:
- 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.


02/09/2022 12:00:00
USD 75.00 90.00 Hour
Contact Consultant:
Jennifer Law

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