Device Engineer II
South San Francisco, CA | Contract
Bayside Solutions is seeking a friendly, energetic and hardworking Device Engineer II. This is a unique opportunity to join a growing team of business professionals focused on treatments to help individuals with diseases that affect the functionality of an individual.
A successful Device Engineer II must have strong customer service skills, be a team player, and provides a great attitude to the team. They are one who is organized, diligent and provides positivity to the work environment.
The culture is based on the idea of others. They pride themselves in their commitment to finding cures that other biotech companies have not tackled.
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.
- Offers their employees a great work/life balance.
- Competitive compensation
- This position is eligible for medical, vision, dental benefits, paid sick time and 401k.
Summary of Responsibilities: The successful candidate will support new product design, development and implementation of delivery devices and novel injection tools/aids for biologic therapeutics.
- Primary technologies include auto-injectors, patch infusers/pumps, and needle stick prevention devices utilizing pre-filled syringes and cartridges.
- Major responsibilities will include the execution of mechanical and analytical testing to support the selection, design verification, commercialization and marketing of various designs.
- This will include the execution of routine and on-going R & D stability testing, design verification testing, complaint investigations and special testing requests.
- He/she will work with design engineers and the laboratory manager to identify, develop, implement, qualify and validate new testing equipment and methods to meet capability and capacity needs of the Device Development department, manage laboratory inventory, maintain equipment calibration and qualification status, troubleshoot equipment failures, and ensure sample traceability and data integrity.
- The person will provide input and execute plans to maintain and improve laboratory safety.
- The successful candidate will be able to support the design engineer in data analysis and interpretation, to identify questionable results and identify root cause.
- The ideal candidate will have a B.S. degree in Engineering Technology, a physical, chemical or biological science or the equivalent.
- Experience in the Pharmaceutical, Biotech or Medical Device industry is preferred, with direct experience in executing physical test methods, procurement and qualification of equipment, development and validation of test methods leading to the successful launch of combination products or medical devices.
- The candidate must be highly organized and detail oriented. The candidate must have expertise in electrical/mechanical instrumentation, data acquisition, maintenance and integrity.
- Excellent verbal and written communication skills are required.
- Experience in R & D, GLP and GMP environments is preferred, and an understanding of the differences for these environments is critical. Experience in developing and building test fixtures and CADD is highly desirable.
- A proven track record of working effectively in a matrix organization with a highly cross-functional and collaborative environment is very desirable.