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 Summary
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.
The Staff System Engineer will be a key contributor to R&D teams focused on new product development. The individual in this position will have extensive technical and design control expertise to support the development of high-quality deliverables.
He/she must have experience working with medical device platforms with an intricate understanding of product development, design controls, and regulatory strategy implications for successful and timely launch of combination products for drug delivery. This position will be a technical leader who can collaborate cross-functionally with key project stakeholders.
The position is location in Franklin Lakes, NJ and reports to the Associate Director of Innovation and Product Development (INPD) in support of the Pharmaceutical Systems business unit.
More specifically your responsibilities will be to:
- Responsible for management of product requirements and high-level design specifications including integration plans of modules and components into a complete system
- Accountable for the planning, execution and documentation of system verification and validation activities.
- Assist cross-functional teams in the development and maintenance of complete, unambiguous, and achievable user needs and design input requirements.
- Assumes a technical leadership role in leveraging internal and external resources to maximize their effectiveness and provide analysis to leadership teams for resource planning.
- Act independently within team expectations, providing guidance, training and direction of work assignments to less experienced team members; consults with functional leadership to identify associates to complete tasks under his/her accountability while balancing a high level of autonomy in daily activities.
- Contributes to product conceptualization and develops work plans to reduce concepts to design
- Provide engineering support to the New Product Development team by guiding the development of a comprehensive design control strategy that ensures compliance with standard operating procedures (SOP) while also being aligned with project needs.
- Collaborate with R&D, Regulatory, Clinical, Marketing, and other functions, to facilitate compliance to applicable requirements during the product development lifecycle and new product commercialization.
- Assist project teams in the compilation of design history files to align with ISO 13485, ISO14971 Risk Management and IEC 60601 and other applicable regulations
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality system/design control issues. Be a change agent in the organization to resolve repeated issues and implemented robust best practices.
- Apply innovative & logical risk-based approach to product development challenges with a capacity for original thinking.
- Identification and implementation of opportunities for functional excellence.
- Exhibits well-developed soft skills when interacting with members of the project team, cross-functionally, and with manager
- Bachelor’s degree in relevant field (Systems/Mechanical/Biomedical Engineering) with minimum of 10 or more years of progressive work experience demonstrating increased proficiencies.
- Master’s degree in relevant subject area (Systems/Mechanical/Biomedical Engineering) with minimum of 8 or more years of progressive work experience demonstrating increased competencies.
- PhD in relevant field (Systems/Mechanical/Biomedical Engineering) with minimum of 6 or more years of progressive work experience demonstrating increased competencies.
- DFSS Green Belt certification is desirable.
Knowledge, Skills and Abilities:
- Experience with Systems Engineering approaches to Combination Product development (ie. Auto-Injector, Wearable Injector, etc.)
- Comprehensive knowledge and experience developing medical device products that comply with ISO13485, ISO14971, and FDA 21 CFR 820 regulations.
- Experience with requirement and specification management for FDA regulated products
- Strong technical judgment and extensive technical leadership skills.
- Proven capability of leading R&D product development projects.
- Demonstrated understanding of the requirements management process, with experience in design verification strategy and implementation.
- Excellent understanding of medical device product development risk management methodologies.
- Excellent written and oral communication and social skills are critical
- Experience as member of project team and leader of a project team
- Experience in guiding team/individuals to develop technical solutions to sophisticated problems.
- Sound knowledge of engineering first principles.
- R&D functional planning, requirement generation and technical (DFSS/design/cross-functional) reviews for all product development phases.
- Ability to communicate concepts, ideas, and knowledge effectively & clearly to other individuals and teams.
- Experience in directing associates and leading small cross-functional groups as required.
- Disciplined phase-gate product development processes & project planning.
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
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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.