Senior Advanced Manufacturing Engineer

RXinsider LTD.; Irvine (CA); On-site; USD 106,000 - 169,000; Full time

Job summary

BD is seeking a Manufacturing Engineer in Irvine, CA to support and optimize manufacturing processes, equipment, and methods in an FDA-regulated setting. The role partners with QA, R&D, and Operations to enable new product introductions, process validations, and continuous improvement.

Requirements include a mechanical engineering degree with 6–8 years (or 2–6 years with a Master’s), experience in FDA manufacturing, and strong English writing skills.

Qualifications

• Bachelor's degree in Mechanical Engineering or a related engineering discipline with 6-8 years of relevant experience, or Master's degree with 2-6 years of relevant experience.
• Experience working in an FDA-regulated manufacturing environment.
• Strong partnership and collaboration skills with Quality Assurance and R&D teams.
• Fluent English communication skills, both written and verbal.
• Strong technical writing and documentation skills.

Responsibilities

• Establish and maintain manufacturing documentation, procedures, drawings, and technical records.
• Develop, implement, and improve manufacturing processes and methods to enhance operational performance.
• Lead transfer of new products from R&D into manufacturing.
• Train production operators on manufacturing processes, equipment, and procedures.
• Lead manufacturing projects and process improvement initiatives.
• Maintain technical services and facilities performance metrics.

Skills

FDA-regulated environment

Collaboration with QA/R&D

Technical writing

Education

Bachelor's degree in Mechanical Engineering or related field

Master's degree in Mechanical Engineering or related field

Tools

SolidWorks 3D CAD

Microsoft Project

Job description

We Are The People Who Give Possibilities Purpose

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.

Job Description

Position Summary

The Manufacturing Engineer is responsible for supporting and improving manufacturing operations through the development, qualification, implementation, and optimization of manufacturing processes, equipment, and methods. This role partners closely with Quality Assurance, R&D, and Operations teams to support new product introductions, execute process validations, lead manufacturing improvement projects, and ensure efficient, compliant manufacturing performance in an FDA-regulated environment.

Key Responsibilities

Manufacturing Engineering & Process Development

• Establish and maintain manufacturing documentation, procedures, drawings, and technical records.
• Develop, implement, and improve manufacturing processes and methods to enhance operational performance.
• Recommend, design, and implement manufacturing tooling, fixtures, and process improvements.
• Support the successful transfer of new products from R&D into manufacturing.
• Train production operators on manufacturing processes, equipment, and procedures.

Validation & Quality Support

• Develop and execute equipment and process qualifications, including IQ, OQ, and PQ validations.
• Coordinate Non-Conforming Material and CAPA activities in partnership with Quality Assurance.
• Support compliance with regulatory, quality, and manufacturing requirements.

Project Leadership

• Lead manufacturing projects and process improvement initiatives.
• Serve as project leader for product and process modifications.
• Participate in project meetings and ensure timely completion of assigned actions and deliverables.
• Support special projects and continuous improvement initiatives as assigned.

Operational & Technical Support

• Maintain technical services and facilities performance metrics.
• Prioritize equipment repair efforts to minimize manufacturing downtime when multiple issues arise simultaneously.
• Coordinate daily workflow and delegate tasks to meet operational objectives.

Team Leadership & Development

• Supervise manufacturing and engineering technicians as needed.
• Support the selection, onboarding, training, development, recognition, and performance management of team members.
• Build a highly skilled and accountable team through coaching, goal setting, mentoring, counseling, and performance feedback while maintaining appropriate records.

Required Qualifications

• Bachelor's degree in Mechanical Engineering or a related engineering discipline with 6-8 years of relevant experience, or Master's degree in Mechanical Engineering or a related engineering discipline with 2-6 years of relevant experience.
• Experience working in an FDA-regulated manufacturing environment.
• Strong partnership and collaboration skills with Quality Assurance and R&D teams.
• Fluent English communication skills, both written and verbal.
• Strong technical writing and documentation skills.

Preferred Qualifications

• Experience working in cleanroom manufacturing environments.
• Experience supporting liquid filling processes.
• Experience using engineering and project management software such as SolidWorks 3D CAD, Microsoft Project, or equivalent tools.

Work Environment

Travel

• Approximately 5% travel may be required.

Physical Demands

• Regularly required to stand, walk, and sit for extended periods.
• Occasionally required to lift or move up to 50 pounds.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the role.

Mental Demands

• Moderate to high degree of concentration required due to workload volume, complexity, and competing priorities.

Work Authorization

Applicants must be authorized to work for ANY employer in the United States. We are unable to sponsor or take over sponsorship of an employment visa at this time.

Why Join Us?

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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.

Primary Work Location

USA CA - Irvine Neomend

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

$105,500.00 - $168,800.00 USD Annual