Quality Engineer - Combination Products

Job Description Summary

This position supports product leadership and risk management of new product development and sustaining activities for combination products. The role may include aspects of manufacturability, scalability, manufacturing transfer and post launch sustainability of combination products.

We 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 Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

This position supports product leadership and risk management of new product development and sustaining activities for combination products. The role may include aspects of manufacturability, scalability, manufacturing transfer and post launch sustainability of combination products.

• Technical leadership skills including an understanding of medical device operations (e.g., medical device manufacturing, process development, quality assurance) and chemical and pharmaceutical operations (e.g., drug product manufacturing, analytical testing, process development and quality assurance)
• Ability to create, support, review, and investigate analytical test methods used to support pharmaceutical combination devices.
• The ability to create, support, review chemistry, manufacturing, and controls device submissions
• Participates as team leader or as an active member of the team to meet company objectives and ensure department responsibilities are completed
• Leads development of risk assessments and test method activities (e.g., development and validation for physical and analytical test methods)
• Leads component qualifications, design validation, design verification, drug stability and process validation
• Leads product investigations
• Ability to make and present risked based decisions
• Assess product changes against product design
• Supports translation of design inputs into manufacturing control plans
• Develop and implement procedures to comply with corporate and industry standards.
• Coordinates and/or directs all aspects of product development activity related to a product line
• Leads development of risk assessments and test methods
• Quality engineering representation on Product Development and Design Review teams
• Prepare and present project updates and technical discussions
• Participate in project planning, budgeting, scheduling, and tracking
• Support internal and external supplier audits
• Provide support to the regulatory department in writing technical submissions
• Complies with company procedures and policies, government regulations
• Actively participates in training and providing input to training of employees on division procedures and policies
• Ability to travel for business, project, and issues approximately up to 25% of time.
• Other duties and projects, as assigned

• BS in Engineering, biological science, or a related engineering field (Masters or Ph.D preferred). Fields of study include Chemical Engineering, Bioengineering, Pharmacy, or Biochemistry
• Minimum of eight years of experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent industry
• Pharmaceutical or combination product experience preferred

• Knows how products are used and impact the user(s) so that risk can be managed effectively
• Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.)
• Ability to lead creation of risk management files
• Ability to develop solutions with business impact
• Advanced statistical and risk assessment techniques
• Working knowledge of test method (development and validation), equipment qualifications, process and design…