Job Description Summary
The manufacturing sterilization engineer provides subject matter expertise for the operation, maintenance, and improvement activities to ensure safe, reliable, and sustainable operations on site.Responsible for the implementation of project and process support activities toward attainment of departmental and plant goals. Primary focus in areas of safety, throughput, quality, and cost improvement programs.
Job Description
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.
Responsibilities:
The primary focus of this role is direct engineering support for a new sterilization facility. The facility has sterilization equipment that is highly technical. The facility also features fully automated material handling systems. The role will identify needed improvements for the equipment, and work with plant resources including operators, technicians, and QA to implement those improvements.
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Directs personnel in the troubleshooting and maintenance of electrical and mechanical systems used in the production process. Support troubleshooting includes occasional nights and weekends as needed.
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Supports the plant manufacturing efforts for continuous improvement in the areas of safety, quality, production, and cost.
Responsible for drafting protocols, test execution, and report generation for process and equipment qualification.
Required to document all new designs or modifications per plant policies and procedures. This documentation includes validations, change control forms, work instructions, machine specifications, schematics, software revisions, spare parts, and maintenance schedules, protocols, reports as applicable.
Ability to handle projects of moderate scope, requiring coordination between vendors, R&D, and plant manufacturing functions.
Works within required safety and quality standards for the equipment.
Recommends vendors for commercial items and materials needed for a project.
Keeps abreast of e-beam related best practices in project management, engineering, and maintenance.
Initiates changes to practices and procedures to support continuous improvement and ensure compliance with applicable regulations.
Works closely with all relevant functions (e.g., Sterility Assurance, Quality, Regulatory, EHS&S, GRC, Supply Chain, Operations) to ensure compliance with global standards and applicable regulations (FDA, EPA, OSHA, DOT, FM Global, NRC, AAMI etc.).
Support the assessment and documentation of risk and hazard analysis.
Requirements:
- 3+ years of manufacturing experience, preferably with automated equipment.
- 3+ years of experience with medical device or other regulated industries preferred.
- Bachelor’s degree in engineering (preferred electrical or mechanical), science, or related degree.
- Experience with electron beam accelerators a plus.
- Familiar with sterilization concepts and standards.
- Process development experience
- Knowledge of analytical and statistical tools
- Green Belt / Black Belt on Six Sigma Training is a plus
Competencies:
- Demonstrated experience in equipment operation, and maintenance.
- Understand the root cause of technical issues, develop a plan, and implement.
- Troubleshooting and repair, equipment calibration knowledge.
- Read and understand drawings, electrical diagrams, chronic levels of quality, waste, and equipment efficiencies.
- Competency in AutoCAD, Solidworks, or equivalent applications for basic mechanical design.
- Perform calculations regarding equipment loading and capacity.
- Effective influencing, communication and presentation skills, and the ability to exercise sound judgment under pressure.
- Agile decision-making skills.
- Effective skills in coaching, influencing, and mentoring.
- Applies knowledge and skills to a wide range of standard and non-standard situations.
- Works independently with minimal guidance.
- Usually determines own work priorities.
- Acts as a resource and mentor for colleagues with less experience
Certifications:
- PE, PMP desired
- Knowledgeable in Six Sigma (greenbelt or blackbelt preferred)
Other Requirements:
- Minimal required supervision
- Set priorities among multiple tasks
- Demonstrate effective leadership
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
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Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.