- Designs, develops and implements new products and processes of a medical device, translating intangible design inputs into tangible engineering specifications and drawings and makes and presents engineering decisions.
- Participates and leads cross-functional teams in the design of a medical device and contribute ideas and/or generate intellectual property submissions.
- Develops new chemistries for medical devices and contributes to the scale up of chemical processes to production readiness.
- Develops new processes by understanding key process inputs and outputs, using statistic methods such as DOE as appropriate.
- Develops new process equipment and tooling, including specification development, vendor selection and negotiation.
- Write and review product development plans, design reviews, technical documents and reports.
- Prepare and approves verification and validation protocols and reports and develop and implements procedures/policy.
- Develop new engineering test methods and clinically relevant simulated use test methods in conjunction with R&D technicians; prepare and assist in the validation of test methods.
- Conduct engineering and competitor evaluations, and development unit testing.
- Plan, develop, execute and manage verification and validation activities for new products and processes.
- Train technicians and engineers on new design and process development as well as new test methods.
- Mentor/coach R&D technicians and engineers through New Product Development activities.
- Support Manufacturing, Quality, Regulatory & R&D to ensure systems are compliant with all internal and external guidelines.
- Support/lead design and process root cause analysis and support non-conforming product and complaint investigations.
- B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline.
- 6-9 years of industrial experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment.
- Demonstrated hands-on technical aptitude.
- Chemistry Experience/Chemical Engineering Experience
- Experience in process validation (IQ, OQ and PQ), writing protocols and reports to support verification and validation activities for product commercialization; ability to execute validation.
- Ability to create and execute project plans.
- Ability to lead cross functional teams.
- Basic tooling, design and drafting knowledge.
- Excellent oral and written communication skills.
- Ability to analyze data, interpret results, and write reports. Proficient in statistic software.
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Director, Medical and Scientific Affairs, ADDS platform and innovation - Franklin Lakes, United States - BD (Becton, Dickinson and Company)
Description
Job Description SummaryWe 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.
Why join us?
A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture.
You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.
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.
Become a maker of possible with us
Job Description
About the role
This position works cross-functionally to lead research and development efforts of complex medical devices.
The position designs, develops and implements new products, focusing on chemistry development and scale up, project planning, innovative medical device design, prototype development, testing characterization, analysis and reporting.
Main responsibilities will include:
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.
To learn more about BD visit:Primary Work Location
IRL Wexford - Enniscorthy
Additional Locations
Work Shift
