Job Description
- Our client is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.
JOB DESCRIPTION:
DO WORK THAT MATTERS
At Bioethic, diverse ideas, perspectives, and expertise allow us to create life-changing solutions that help people live healthier lives. In 150 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Bioethic offers you enormous opportunities to explore your interests and help you achieve your career and personal goals.
We have an exciting opportunity for a Principal System Integration Engineer within our business located at San Diego, CA. In this role, you will provide technical expertise to the design and development of point-of-care, rapid in vitro diagnostics (IVDs) for Infectious Diseases.
RESPONSIBILITIES
This role contributes to the design and development of single-use test devices for rapid in vitro diagnostics (IVDs). This individual works with the project team through multiple design, prototype, and test cycles to evolve the product from concept to qualification. Working with Assay Scientists, Consumable Designers, Manufacturing Engineers, Software Engineers and Instrumentation Engineers, they will develop product solutions to extend the test menu on the existing platform and concepts for new platforms. As the development progresses, they will be responsible for design documentation, engineering studies, and design verification protocols/reports in accordance with the governing QMS. The ideal applicant has a strong background in the development of IVDs, either in an academic lab or diagnostics company.
Tasks and responsibilities:
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- Acts in a lead systems integration role to ensure the engineering and biochemistry elements of the design are coordinated.
- Investigates and evaluates existing technology for application in a product.
- Uses fundamental engineering principles to aid in the design and testing of the product.
- Sets and justifies specifications across system level components.
- Designs experiments, evaluates data, and makes recommendations based on data.
- Conducts feasibility studies across system level components to ensure designs are functioning as intended.
- Uses data driven recommendations to ensure system operates at a high level of quality.
- Interfaces with cross-functional project team to ensure design requirements are met and product meets quality standards.
- Maintains detailed documentation throughout all phases of research and development and assist in transfer to manufacturing.
- Aids in the coordination of activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines.
- Provides technical input for FMEAs and determines risk mitigation strategies/designs.
- Identifies and communicates with key contacts outside own area of expertise.
- Other duties as assigned, according to the changing needs of the business.
QUALIFICATIONS
Required:
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- B.S Degree in Mechanical, Chemical, Electrical, Bioengineering or similar field with 8+ years of experience
- Experience working with in-vitro diagnostic devices
- Demonstrated problem-solving and troubleshooting skills
- Strong verbal and written communication skills
- Organized and detail oriented
- Ability to work in a team environment
Preferred:
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- Experience in medical device development under design controls
- Knowledge of microfluidics, molecular assay architecture, and manufacturing techniques
- Proficient in Solidworks
JOB FAMILY:
Product Development
LOCATION:
United States > San Diego
WORK SHIFT:
Standard
TRAVEL:
Yes, 5 % of the Time
SIGNIFICANT WORK ACTIVITIES:
Lift, carry, push or pull weights of more than 20 pounds/9 kilos on a regular/daily basis