Associate Staff Engineer - Sustaining

BD

66d

About The Position

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 MedTech 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. Associate Staff Engineer - Sustaining Summary: The Associate Staff Sustaining Engineer will support new product development and sustaining engineering activities of vascular access devices in all stages of the product life cycle. This includes supporting design, testing, manufacturing, clinical evaluation, regulatory clearance/approval, marketing, sales, training, and post-market surveillance. The candidate will be responsible for ensuring products are safe and effective by developing test methods, executing device evaluations, interpreting data results, authoring technical documents, and presenting findings to management. In addition, the individual will be responsible for communicating requirements to suppliers and managing external resources to meet project milestones on time and within budget. The ideal candidate should have experience in medical device industry or related field. Knowledge of FDA regulations, IEC standards, ISO 10993, and quality system requirements such as MDSAP would be beneficial. Experience with design control process, risk analysis, and conducting human factors studies is required.

Requirements

• Bachelor’s degree in Engineering or Science discipline plus minimum of 8 years relevant experience OR Master’s degree in Engineering or Science discipline plus 6 years relevant experience.
• Medical device industry experience preferred.
• Ability to understand complex business processes and develop efficient solutions.
• Strong communication skills (written and verbal).
• Ability to travel domestically and internationally approximately 5% of time.
• Proficient computer skills (Microsoft Office Suite).
• Demonstrated ability to handle multiple competing priorities simultaneously while meeting deadlines.
• Ability to interpret data, draw reasonable conclusions, and make sound decisions based upon available information.
• Familiarity with Design Control Process and Risk Analysis.
• Working knowledge of FDA regulations (21 CFR Part 820), IEC Standards (60601 series), ISO Standards (14971, 13485, 10993), and quality system requirements (MDSAP).

Responsibilities

• Supports all phases of new product development and sustaining engineering activities including design, testing, manufacturing, clinical evaluation, regulatory clearance/approval, marketing, sales, training, and post-market surveillance
• Develops/update user documentation (e.g., specifications, protocols, reports) according to applicable FDA regulations, IEC standards, ISO 10993, and quality system requirements.
• Manages external resources to ensure timely completion of projects.
• Communicates requirements to suppliers and ensures they are met.
• Works closely with multi-functional teams to execute project plans.
• Performs activities in compliance with SOPs and other quality systems requirements.
• Participates in audits and inspections as needed.
• Applies fundamental knowledge of engineering fundamentals.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Builds productive internal/external working relationships.

Benefits

• On-site collaboration to foster creativity and innovation.
• Flexibility and work-life balance.
• Opportunities for learning and growth.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree