Job Description Summary

Job Description

Job Description

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. This experience offers the combination of agility and creativity of a high-growth, start-up environment along with 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
• Drive the design of products for high volume manufacturing, ie. Suitable for plastic injection molding, die cast molding, automoated assembly/packing processes, etc.
• Administer the application of Design for Manufacturing/Assembly (DFM)
• Oversee 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

Required Experience:

• 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) or similar;
• BS 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;

Preferred Experience:

• MS in Mechanical, Materials Science, or Biomedical Engineering or closely related disciplines preferred;
• 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.

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