Staff Engineer, New Product Development, R&D - United States
As a member of the BD Pharmaceutical Systems Self-Administered Injectable Systems (SAIS) business, you will have the unique opportunity to play a vital role in the rapid scale-up of an exciting new business platform that will be a key contributor to BD’s future growth. Our mission is to become a world-class, customer focused organization that will have a significant impact in improving how patients receive drugs for their chronic conditions. You will have the advantage of combining the best of both worlds: the agility and creativity of a high-growth, start-up environment, and the backing and resources of a Fortune 500 company.
This team member should share our passion for excellence and innovation while actively building on their motivation to design and build this family of self-administered injection products from the ground up.
The new hire will join a New Product Development team and will be responsible for leading and/or participating in the design and development activities from concept all the way through commercial launch of the product. Activities will focus on identifying, articulating, and quantifying customer needs and requirements; translating these requirements to product requirements and specifications; assessing the suitability of current designs and technologies to meet these requirements; and, where necessary, developing and implementing innovative design solutions to address needs or gaps.
More specifically your responsibilities will be to:
- Lead aspects of design and development for a variety of drug delivery products in a design control environment
- Design products for high volume manufacturing, ie. Suitable for plastic injection molding, die cast molding, automoated assembly/packing processes, etc.
- Application of Design for Manufacturing/Assembly (DFM)
- Tolerance stack-up analysis for complex mechanical assemblies
- Provide guidance for FEA analysis and in interpreting results
- Analyze and draw conclusions from test data for improving product performance
- Manage and assess external vendors/supplier work and capabilities
- Conduct design reviews, FMEA's and design verification programs
- Generate imaginative yet practical technical solutions to a wide range of difficult problems.
- Exhibit an understanding of customer needs and processes to ensure relevant and innovative product development solutions.
- Demonstrate technical rigor and creativity, continuous learning and improvement, and alignment to customer needs and value creation
- Demonstrate strong and clear accountability/responsibility for successful and timely completion of designated tasks
- Contribute to a culture of innovation by proactively generating novel concepts to improve product performance or enhance products' ability to address customer needs
- Minimum of 8 years’ experience as a product design / development engineer and/or project engineer in the medical device or pharmaceutical industries (experience with FDA class II or III medical devices preferred);
- MS in Mechanical, Materials Science, or Biomedical Engineering or closely related disciplines preferred;
- Experience with developing products or implementing product changes through a structured, phase-gated, product development process;
- Experience identifying (through a variety of methods, including observation and solicitation), articulating, and prioritizing customer needs and requirements
- Demonstrated experience designing complex components for high volume manufacturing methods such as plastic injection molding, die casting, compression molding, etc.
- Demonstrated understanding of product development considerations for tightly controlled, high-volume manufacturing processes;
- Demonstrated experience with all phases of the Design Control process;
- Demonstrated understanding of the requirements management process, with demonstrated experience in design verification strategy and implementation;
- Demonstrated experience in a technical role on a cross-functional team, leadership role preferred;
- Excellent understanding of medical device product development risk management methodologies;
- Proficiency with statistical techniques;
- CSWP Certified SolidWorks Professional a plus
- Clear understanding of manufacturing process validation including FAI/FAT, development and IQ/OQ/PQ;
- Basic understanding of IP considerations;
- Intellectual curiosity coupled with strong analytical and problem-solving skills;
- Demonstrated ability to clearly and effectively communicate (verbal & written) concepts; and
- Demonstrated versatility and learning agility
- Proficiency in tolerance stack-up analysis involving multiple components;
- Design and execution of user studies in support of product requirement specification development
- Experience with designing for high-volume manufacturing methods such as plastic injection molding and automated assembly/packaging processes;
- Experience with design optimization for multi-component mechanical assemblies or systems involving injection molded and compression molded components;
- Clear understanding of fixture design including basic machining considerations and Measurement Systems Analysis (MSA),
- Experience using advanced engineering tools such as Design for Six Sigma or Six Sigma methodologies, Black Belt is a plus.