- BD - Medical Surgical Systems has an exciting opportunity to join the team to develop new products for our core product portfolio.
- Within BD Medication and Procedural Solutions (MPS) Research & Development, the associate in this position will have a unique opportunity to be part of the WW Injection Systems platform and will significantly contribute to BD's future growth.
- The team is seeking a highly talented and passionate individual to help the team identify and implement innovative solutions to address current and future health care needs in the drug administration market.
- The associate will contribute to the design, development and commercialization of medical device products that address opportunities to improve drug delivery.
- The new hire will join a New Product Development team and will contribute to the design and development activities focused 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 technical solutions to address needs or gaps.
More specifically your responsibilities will be to:
- Actively participate in and lead aspects of design and development activities for hypodermic products
- Provide developing technical expertise and engineering excellence to medical device product development projects
- Expand our technical capabilities by building a strong internal network
- Demonstrate technical rigor and creativity, continuous learning and improvement, and alignment to customer needs and value creation
- Aspire to and develop toward technical, project, or people leadership roles
- Execute technical and/or cross-functional project work
- Contribute to a culture of innovation by proactively generating novel concepts to improve product performance or enhance products' ability to address customer needs
This important position requires the following qualifications:
- Minimum of 3 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 (PhD 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 with all phases of the Design Control process;
- Demonstrated understanding of product development considerations for tightly controlled, high-volume manufacturing processes;
- Clear understanding of manufacturing process validation including FAI/FAT, development and IQ/OQ/PQ;
- 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;
- Proficiency in Microsoft Project or equivalent project planning software is a plus;
- 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 one or more of the following areas
- 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 molding and stamping, and automated assembly and 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.