Device Engineer I/II
500 Forbes Boulevard South San Francisco, CA 94080
Bayside Solutions is seeking a Device Engineer I/II 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.
Device Engineer I/II
- 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:
- The Device Development department is searching for a dynamic Device Engineer to bring innovative drug delivery devices into clinical and commercial production to support the client’ s next-generation drug pipeline.
- The candidate is expected to have technical expertise in the development of drug-device combination medical products, and be able to provide technical leadership to support engineering, scientific, and manufacturing activities.
- The candidate will be assigned to teams developing leading-edge mechanical drug delivery devices while meeting the highest standards of quality and reliability.
- The candidate will be responsible for providing design, development, and commercialization support to project teams that are developing combination drug delivery devices for parenteral pharmaceutical therapeutics.
- The candidate, working with senior engineers and scientists, will work independently with general direction from project teams or functional management. The work is reviewed upon completion
- Proven experience in providing engineering technical input to a team composed of internal members along with external development partners and component suppliers is required.
- The ability to interact at a detailed technical level with process, human factors, and industrial engineers is also an essential skill.
- Device Engineering development:
- Primary: Develop designs that provide the most cost effective, robust and reliable performance for medical devices
- Characterize device designs using appropriate tools such as DOEs, components of variance, house of quality, probabilistic design, etc.
- Characterize important material attributes (MAs) using appropriate tools such as tolerance analyses, empirical / mechanistic modeling with Monte Carlo simulation, etc.
- Identify design input requirements, ensure compliance with standards and SOP’ s and support development of control system/design transfer.
- Procure lab-scale testing equipment. Design, fabricate, and procure fixtures for device evaluation
- Review change requests associated with design of the product
- Design Controls, risk management, and cGMP for biologics, pharmaceuticals, and medical devices.
- Primary: 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, design verification, design validation, failure modes effects and analysis, risk management plans, change management plans and design review meeting minutes.
- Understand, implement and maintain Roche Pharma Quality Policy and Pharma Quality System (PQS) in the department.
- Use (and create and implement, if necessary) local procedures and templates ensuring alignment with current versions of PQS documents and best practices.
- Assist with resolving issues due to internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions.
- Create and review discrepancy, change and risk management documents for devices teams.
- Ensure compliance of training to PQS and job-related requirements.
- Participate in and draft (as applicable) hazards analyses, design assessments, and design reviews.
- Internal/External Supplier and Contract Manufacturer Collaboration
- Collaborate with internal / external teams to translate design requirements into clinical and commercial processes
- Ensure product quality and design requirements are traced through the development process.
- Assist and support testing and evaluation performed at supplier
- The job may require visual inspection, testing, and manual assembly of components and devices
- Assemble test samples.
- Inspect, sort, and test device components.
- Complete cGMP records to document builds.
Summary of Qualifications:
- Advanced degree, B.S., or M.S., in engineering or related discipline, with preference for Mechanical Engineering, or the equivalent.
- 4 years of experience in industry or academia (including advanced studies) after receiving their Bachelor’ s Degree.
- Experience collaborating with internal and external suppliers and providing technical support to internal cross functional teams
- Prior experience with Design Controls
- In depth experience with design controls, test method development, and design verification methodologies is also required.
- Drafting of device design verification protocols/reports and conducting design verification testing.
- Expertise in CAD (Solidworks preferred), Rapid prototypting, material selection/biocompatibility, DFX, etc.
- Proven experience in test method validation and Gage R&R
- Experience statistical analysis and interpretation of data.
- Familiarity with risk management tools (developments of pFMEAs, etc.).
- Highly organized, detail oriented and strong communication skills including technical report reviewing and writing.
- Experience with GD&T
- Operating Machine Shop Equipment
- Lean/Six Sigma
- Strong technical skills in probabilistic design, tolerance analysis and design for manufacturing and assembly
- Experience working in a highly cross functional (e.g. Matrix) and collaborative environment