Be part of something bigger at BD. Here, you’ll join a driven, agile engineering team working in a startup-like environment that has the backing and resources of a Fortune 500 company. In engineering, you could be involved in everything from operations, production and construction to information technology and maintenance environments, all while analyzing and developing solutions to further our engineering capabilities. You’ll use your talent and track record of solving complex problems to achieve one singular goal: advancing the world of health™. At BD, you can make a true difference of one.
Job Description SummaryBe Part of Advancing the World of Health!
You will utilize your product development and biology/microbiology experience and expertise to plan, design, build, and qualify measurement systems and methods vital to the evaluation of product safety, efficacy, performance, and compliance while ensuring accurate completion of project and business goals
Be part of something bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We support the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 65,000 employees have a passion and dedication to help improve the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most complicated global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
Within our CCMD (Catheter Care and Medication Delivery) business, the Medication Delivery Product Engineering team is seeking a Senior Engineer to join us. In this exciting role, you will change health care by driving commercialization of new products and design changes for current products through all phases. You will apply your product development and biology/microbiology experience and expertise to plan, design, build, and qualify measurement systems and methods vital to the evaluation of product safety, efficacy, performance, and compliance while ensuring accurate completion of project and business goals. You will develop and drive the strategy and execution of product design verification and validation activities to demonstrate product safety, efficacy, performance, and compliance. You will support the development of the product designs and associated requirements to efficiently demonstrate their safety and efficacy.
Duties & Responsibilities
This role will provide subject matter expertise (SME) in the areas of:
- Biological/microbiological and analytical testing development and methodologies for medical devices, materials and combination products.
Including leading and supporting routine and non-routine USP, ASTM, ISO, and CLSI based microbiological testing for anti-infective, antiseptic, or disinfectant efficacy (i.e., time-kill assay, MIC/MBC, sterility testing, microbial limits, bioburden, neutralization validation).
- Develop test methods and craft requirements in the subject matter area which follow innovative and industry practices and standards not limited to USP, ASTM, ISO and CLSI.
Apply rigorous and innovative approaches for development of microbiological, biological and analytical test methods for novel and non-compendial product evaluations.
Understand and proliferate best practices as it relates to biological/microbiological testing.
Serve as organizational SME for:
- Biological/Microbiological test method validation
Regulatory and organizational strategies as they relate to Biological/Microbiological requirements and test methods
- Support preparation of responses to regulators
Statistical analysis of method outputs, sample sizes related to and used in method validation.
Plan and support through all project phases with a focus on the strategy and execution of design and development, measurement system development/qualification, design verification and design validation.
Independently support product development projects and optimally define problems, collect and interpret data, establish facts, draw valid scientific conclusions, and propose solutions or corrective actions.
Craft, edit, and interpret technical drawings and technical reports and write protocols, reports, work instructions, presentations, etc.
Expertly apply engineering principles for design/analysis and complete statistical analysis and sample plan development.
Demonstrate accountability for the successful and timely achievement of goals.
Present to peer and stakeholder audience on are of expertise to empower the organization and disseminate data and conclusions
Education & Experience
Minimum 5-6 years of experience in medical device or other regulated industry OR Master's Degree in Mechanical/Biomedical/Bioengineering Engineering and 3+ years of experience OR PhD in Mechanical/Biomedical Engineering/Biology and 3+ years of experience.
Expertise with biological and microbiological testing of medical devices, associated lab practices and standards is required.
Expertise with test method development, validation strategy, and validation execution is required.
Expertise with design verification & validation strategy development and execution is required.
Consistent track record of technical problem solving and effective product development through experienced application of engineering/biology principles is required.
Design controls expertise and experience with traditional and modern fabrication techniques is a plus
Experience in packaging testing methodologies and industry standards is a plus
Experience in solid modeling (SolidWorks) or electromechanical systems is a plus.
Experience in high-volume manufacturing processes is a plus.
Experience developing and commercializing medical devices is a plus
Exposure to Chemistry/ Chemical Engineering is desirable.
Knowledge, Skills & Abilities
Ability to lead and teach others to assess project/program needs, formulate strategy, build support, and implement initiatives.
Strong interpersonal and decision-making skills and the ability to effectively lead change and uncertainty.
Ability to engage and mentor team members and to enhance diverse perspectives to achieve the best outcomes.
We offer a comprehensive Total Rewards program aimed at the varying needs of our diverse and global associates. The sum of our programs and policies, which includes pay, benefits, recognition, life balance, career and community components, is one of the many reasons people choose to work at BD.
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 empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
To learn more about BD visit https://jobs.bd.com/
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.
Primary Work LocationUSA NJ - Franklin Lakes
Work ShiftNA (United States of America)
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Advancing the world of health™
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
As a new employee what I like most about BD are the many learning and professional developmental opportunities for growth offered. It is good to know that there are so many resources to choose from.
Since joining BD, I really have liked the people I work with on a daily basis and the collaboration towards common goals.
Senior Program Manager
BD is full of passionate, loyal, and driven people that have a common goal of advancing healthcare without sacrificing quality or service.