Senior Project Engineer
1 DNA way South San Francisco, CA 94080
Bayside Solutions is seeking a Senior Project Engineer to be part of our client’ s team in South San Francisco. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Sr Project Engineer
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Works independently and provides oversight of device quality engineering activities during product development.
- Be the responsible quality oversight during device development.
- Provide quality oversight for the Design History File and Risk Management File according to Design Control and Risk Management processes
- Perform any other tasks as requested by Management to support Quality oversight Activities
- Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
Summary of Qualifications:
- 12+ years’ experience in a Device Development and/or Device Quality Engineering role for a medical device and / or pharmaceutical company
- Experience leading and working with internal and external teams through end-to-end projects
- Able to educate teams and organization on Design Controls and related topics
- Demonstrated capability of ISO13485, 21CFR820 and ISO14971
- Demonstrated capability of applying risk management concepts and tools
- Understanding of the biotechnology industry and specifically combination products.
- Well developed teamwork and collaboration skills and ability to communicate clearly and professionally both verbally and in writing.