Irvine, California, United States · On-site
$84k–$134k/yr
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 …
Skills: Six Sigma, Lean Manufacturing, Process Validation, Project Management, CAD
Irvine, California, United States · Hybrid
$92k–$148k/yr
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less in…
Skills: Analytical Reasoning, Clinical Research And Regulations, Clinical Trials Operations, Coaching, Collaboration
Irvine, California, United States · Hybrid
$109k–$175k/yr
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less in…
Skills: Scientific Writing, Clinical Data Analysis, Project Management, Medical Writing, Interpersonal Communication
Irvine, California, United States · On-site
$149k–$175k/yr
About DZYNE DZYNE Technologies is leading the future of autonomous defense. Based in Irvine, California, we develop and manufacture advanced airborne and ground-based defense solutions deployed in over 50 countries. Back…
Skills: PCB Design, Circuit Design, System Integration, Harness Design, Avionics Testing
Irvine, California, United States · On-site
Overview Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral …
Skills: Program Management, Project Management, Risk Management, FDA Design Controls, Budget Management
Irvine, California, United States · On-site
Who We Are Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation’s top 10 public universities by U.S. News & World Report. The campus has prod…
Skills: Administrative Support, Travel Coordination, Document Management, Calendar Management, Proofreading
Irvine, California, United States · Hybrid
Who We Are Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation’s top 10 public universities by U.S. News & World Report. The campus has prod…
Skills: Clinical Trial Coordination, Data Management, Patient Recruitment, Patient Consenting, Regulatory Compliance
Irvine, California, United States · On-site
$142k–$269k/yr
Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a r…
Skills: Regulatory Strategic Planning, FDA Interface, Product Lifecycle Management, Regulatory Submissions, Strategic Thinking
Irvine, California, United States · On-site
$75k–$90k/yr
RESPONSIBILITIES: Assists in assuring facility, manufacturing, packaging, and Laboratory equipment are qualified to the required cGMP standards.Authors/approves and executes qualification protocols and reports.Schedules,…
Skills: Equipment Qualification, cGMP Standards, Validation Master Plan, Protocol Authoring, Vendor Qualification
Irvine, California, United States · Hybrid
Overview Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral …
Skills: Quality Control, Process Improvement, Design Control, Risk Assessment, Regulatory Compliance
Irvine, California, United States · On-site
$105k–$155k/yr
Join a team where your impact reaches beyond the stars! At Terran Orbital, you’re not just part of the system – you’re a vital force propelling our mission forward. As trailblazers in satellite manufacturing and aerospac…
Skills: SolidWorks, Creo, CAD, GD&T, ASME Y14.5
Irvine, California, United States · On-site
Overview Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral …
Skills: Quality Control, Inspection, Documentation Review, Non-conformity Documentation, Traceability Labeling
Irvine, California, United States · On-site
Job Summary: We are seeking an Engineering Intern, focusing on the design of optical systems within the biotechnology industry. This position is ideal for students or recent graduates with a Bachelor’s or Master’s degree…
Skills: Optical System Design, Mechanical Engineering, CAD Software, SolidWorks, OnShape
Irvine, California, United States · On-site
About Rivian Rivian is on a mission to keep the world adventurous forever. This goes for the emissions-free Electric Adventure Vehicles we build, and the curious, courageous souls we seek to attract. As a company, we con…
Skills: Computational Fluid Dynamics, Multiphase Flow Modeling, Preonlab, PowerFlow, Star CCM+
Irvine, California, United States · On-site
About Rivian Rivian is on a mission to keep the world adventurous forever. This goes for the emissions-free Electric Adventure Vehicles we build, and the curious, courageous souls we seek to attract. As a company, we con…
Skills: Automotive testing, Aerospace testing, Climate chamber operation, Chassis dynamometer operation, Mechanical aptitude
Irvine, California, United States · On-site
About Rivian Rivian is on a mission to keep the world adventurous forever. This goes for the emissions-free Electric Adventure Vehicles we build, and the curious, courageous souls we seek to attract. As a company, we con…
Skills: Structural Testing, Durability Testing, Mechatronics, Sensor Installation, 3D Scanning
Irvine, California, United States · On-site
$90k–$100k/yr
Job Overview: APTIM Environmental & Infrastructure, LLC is seeking a mid-level Environmental Scientist on a full-time basis to work at our Irvine, California office to to participate in a variety of environmental complia…
Skills: Environmental Compliance, RCRA, Hazardous Waste Management, Technical Reporting, Environmental Auditing
Irvine, California, United States · Hybrid
Who We Are Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation’s top 10 public universities by U.S. News & World Report. The campus has prod…
Skills: Grant Operations, Subawards Management, Federal Reporting, IRB Protocol Coordination, Human Subjects Research Compliance
Irvine, California, United States · On-site
Responsibilities ECS is seeking an experienced Specification Writer III to join our Pacific Building Science + Infrastructure team in Irvine, CA. In this role, you’ll collaborate closely with architects, engineers,…
Skills: Specification Writing, Architectural Design, AIA MasterFormat, Product Research, Construction Methodology
Irvine, California, United States · On-site
$23/hr–$25/hr
NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration s…
Skills: Product Preparation, Data Analysis, Reagent Preparation, Laboratory Equipment Maintenance, GMP
Irvine, California, United States • On-site
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Lead the optimization and improvement of manufacturing processes using Six Sigma and Lean methods while managing supplier process validations. Responsible for resolving compliance issues, managing part qualifications, and collaborating with cross-functional teams to ensure supply chain fluidity.
Requires a Bachelor's degree in Engineering with 3 years of experience, or a Master's degree with 2 years of experience. Candidates must possess strong technical skills in CAD, statistical analysis, and knowledge of FDA regulations for medical devices.
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.


Lead in the identification and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc. are up to standards
Drive the development and execution of experiments and tests (including writing and executing protocols) on a simple product line to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports
Collaborate with first & second-tier suppliers on process development and process validation including IQ/OQ/PQ/TMVs.
Initiate and execute part qualification plan and reports.
Establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)
Analyze and resolve Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations)
Lead supplier related notification of changes (NOCs) including end of life (EOL) components and sub-assemblies to maintain fluid supply chain of finished products.
Responsible for inspection method fixture development and implementation and qualification of inspection methods at contract manufacturer’s receiving inspection & sub-tier suppliers’ outgoing inspection.
Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes
Collaborate with internal cross-functional teams, including Regulatory, Quality, Supply Chain, and R&D.
Able to identify appropriate equipment, develop inspection methods, and fixtures to inspect or test Critical-to-Quality features. Perform appropriate Gauge Studies and statistical analysis to verify acceptability.
Ability to read, interpret and modify 2D drawings & 3D CAD to ensure manufacturability and serve as a conduit between supplier and design teams.
Demonstrate structured problem-solving approach for technical and logistical issues.
Other incidental duties
Proven expertise in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)
Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
Basic understanding of statistical techniques
Previous experience working with lab/industrial equipment required (if applicable)
Strong problem-solving, organizational, analytical and critical thinking skills
Minimal understanding of processes and equipment used in assigned work
Knowledge of applicable FDA regulations for medical device industry
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast-paced environment
Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Bachelor’s degree in engineering (preferred Biomedical, Mechanical, or Automotive) 3 years’ experience including either industry or industry/education Required or;
Master's Degree or equivalent in Engineering, 2 years’ experience including either industry or industry/education preferred.
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.
Required Skills
Optional Skills
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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
$83,500.00 - $133,500.00 USD AnnualBD is the world's largest manufacturer and seller of medical equipment.
BD is one of the world's largest medical technology companies that produce and sell medical equipment, medical systems and reagents, dedicated to improving human health around the world. BD focuses on improving drug treatment, improving the quality and speed of diagnosis of infectious diseases, and promoting the research and discovery of new drugs and vaccines. BD has strong research and development capabilities to fight many of the world's most intractable diseases. Founded in New York in 1897, the company is headquartered in Franklin Lake, New Jersey, USA and employs more than 25000 people in about 50 countries around the world. The company's clients include medical institutions, life sciences research institutes, clinical laboratories, industrial units and the general public.
Offices: 纽约, 10001, US
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