Device Engineer II
1 DNA Way South San Francisco, CA 94080
Bayside Solutions is seeking a Device Engineer 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 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 ideal candidate must have Medical Device/Combination Product development experience using procedural controls governed by 21 CFR Part 820 and EU MDR. Experience in working on similar projects using Agile methodology is an advantage. The candidate will also need to have flexibility to work in various time zones and have ability to travel to travel to Switzerland when needed, (after corporate travel restrictions are lifted).
- Evaluate and refine data models to that define business process and structure of deliverables that are used by Siemens developers to configure Polarion system interface
- Develop new/improved processes necessary to maximize the efficiency of the software (eg. risk analysis, data and doc approvals, Design Reviews)
- Identify and prioritize use-cases and product features that align with overall business and product strategy opportunities
- Utilize AGILE implementation methodology to monitor product backlog and prioritization of product development initiatives, working closely with engineering teams to deliver final products
- Conduct user acceptance and feature testing for software development SPRINTS and development releases
- Consolidate user feedback and turn into technical solutions
- Work with Product Teams to migrate data needed to conduct user acceptance testing
- Work closely with team to develop training materials that will be used for onboarding new team members and for the GO LIVE rollout
Summary of Qualifications:
- 5+ years Medical Device Engineering experience for all phases of DHF development.
- Prior experience using Device Design Control PLM tool within a regulated medical device/combination product industry. Experience with Polarion is a plus.
- Flexibility, willingness to learn, and a demonstrated ability to come up to speed quickly when working with new IT business applications and technical issues.
- Must possess strong verbal and written communication skills