Compensation: $107,300.00 - $159,640.00 /year *
Employment Type: Full-Time
Bayside Solutions is seeking an Engineer I
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
.Engineer IJob Benefits:
Summary of Responsibilities:
- 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 Qualifications:
- The engineer in this position will be responsible for supporting device engineering activities within the Device Development department and facilitating product development towards the goal of first human use of novel medical devices. This objective will be accomplished by executing activities in the areas of
- Device Engineering: Provide guidance and input regarding product development. Regularly interface with staff and leaders in Research, Clinical Sciences, Contract Manufacturing, Product Core Teams, Pharmaceutical development, Packaging Development, Quality and Regulatory Affairs. Interact with external development partners and components suppliers.
- Quality Systems Compliance: Understand, implement and apply Client Pharma Quality Policy and Pharma Quality System (PQS) in the department. Use (and create and implement, if necessary) local PTDU-D procedures and templates ensuring alignment with current versions of PQS documents and best practices. Ensure compliance of training to PQS and job-related requirements.
- Design Control: Draft, review and/or approve design control documents (i.e. DHF documents) to support device development deliverables using available templates, such as protocols and reports. Employ good document practices (GDP) when recording data, maintaining archives and drafting and reviewing documents. Participate in hazards analyses and design assessments and reviews.
- B.S, M.S, or advanced degree in Engineering, with preference for Mechanical Engineering, Materials Science Engineering Electrical Engineering, Chemical Engineering, or the equivalent.
- At least 2 years of experience in the industry and/or academia (including advanced studies) after receiving their Bachelors degree.
- Experience in the Pharmaceutical, Biotech or Medical Device industry is expected, with previous work on development of implantable devices highly desired. Must have prior experience working on medical devices and/or combination products.
- Familiarity with relevant modeling and design tools, design controls and/or statistical analysis, for example:
- Engineering: Electromechanical system design, System engineering, Process/Industrial Engineering, Injection molding and Mold-Flow analyses.
- Modeling: Monte Carlo Simulations, Tolerance Analysis, Finite Element Analysis.
- Device Design: CAD, Rapid prototyping, GD&T, Material selection & Biocompatibility, Design for Manufacturability, Molding.
- Data and statistical analysis (JMP, Minitab) and Design of Experiments.
- Design Controls for regulatory compliance & filing (ISO 13485, etc.): GDP/GLP/GMP, Design History Files, protocols/reports, hazards analyses, batch records, etc.
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.