Job Opportunity in Irvine, CA
Join our dynamic team in Irvine, CA, where innovation meets excellence. This role offers a unique blend of hybrid and remote work arrangements, with occasional travel to our Client APM HQ. Enjoy the flexibility of remote work while contributing to groundbreaking projects in the heart of Irvines thriving tech community.
This position is an exciting opportunity to collaborate on projects and initiatives in support of Becton Dickinson’s Advanced Patient Monitoring systems. The role will play a key part in the development and execution of manufacturing and operations strategies, including supporting key projects and initiatives, ongoing manufacturing, new product commercialization, line extensions, interfacing with third‑party providers, and leading product and process improvements.
Responsibilities
* Identify and implement opportunities to optimize and improve manufacturing processes using engineering methods such as Six Sigma and LEAN.
* Use technical principles, problem‑solving skills, and data analysis to support production at contract manufacturers.
* Lead initiatives to support manufacturing projects including material qualification, supplier changes, and product enhancements.
* Manage change control for ongoing manufacturing changes, including CAD updates and change requests.
* Review all incoming PCNs and assess changes in materials, mechanics, and electronics.
* Maintain a tracking system for PCNs reviewed, routed, and approved.
* Develop experiments and tests to qualify and validate manufacturing processes; analyze results and make recommendations.
* Analyze and resolve complex manufacturing and compliance issues.
* Develop training and documentation materials for production processes.
* Lead and establish project plans to ensure deliverables meet customer expectations.
Education and Experience
* Bachelors Degree in Engineering or Scientific field with 5 years of experience, or
* Masters Degree with 4 years of experience, or
* Ph.D. with relevant industry experience.
Additional Skills
* Proven expertise in MS Office Suite and MS Project.
* Knowledge of Windchill PLM and Teamcenter is preferred.
* Proficiency in Mechanical CAD tools such as SolidWorks, CREO, and ProE.
* Strong documentation and communication skills.
* Understanding of statistical techniques and lab/industrial equipment.
* Knowledge of FDA regulations for the medical device industry is preferred.
* Ability to manage competing priorities in a fast‑paced environment.
Preferred Qualifications
* Familiarity with medical device regulations and governance documents.
* Lean Champion and/or Six Sigma certifications.
* Ability to read electronics schematics and mechanical drawings.
* Experience troubleshooting and documenting evaluations of device failures.
J-18808-Ljbffr