Associate Staff Engineer - Sustaining

Associate Staff Engineer - Sustaining (Salt Lake City, UT)

The Associate Staff Sustaining Engineer will support new product development and sustaining engineering activities of vascular access devices throughout the product life cycle. Responsibilities include design, testing, manufacturing, clinical evaluation, regulatory clearance/approval, marketing, sales, training, and post‑market surveillance. The candidate will develop test methods, execute device evaluations, interpret data, author technical documents, and present findings to management. The role also involves communicating requirements to suppliers, managing external resources, and ensuring projects meet milestones on time and within budget.

• Support 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.
• Develop and update user documentation (e.g., specifications, protocols, reports) according to applicable FDA regulations, IEC standards, ISO 10993, and quality system requirements.
• Manage external resources to ensure timely completion of projects. Communicate requirements to suppliers and ensure they are met.
• Work closely with multi‑functional teams to execute project plans.
• Perform activities in compliance with SOPs and other quality systems requirements.
• Participate in audits and inspections as needed.
• Apply fundamental knowledge of engineering fundamentals.
• Exercise judgment within defined procedures and practices to determine appropriate action and build productive internal/external working relationships.
• Report to Manager, Sustaining Engineering.

• Bachelor’s degree in Engineering or Science discipline plus a 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 while meeting deadlines.
• Ability to interpret data, draw reasonable conclusions, and make sound decisions based on 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).

• None specified beyond the qualifications above.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally‑protected characteristics.