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BD (Tissuemed Ltd) · 4 weeks ago

Associate Staff Engineer - Sustaining

Salt Lake City, UT

Full-time

Onsite

Senior Level, Lead/Staff

6+ years exp

BD is one of the largest global medical technology companies in the world, advancing the world of health. The Associate Staff Engineer - Sustaining will support new product development and sustaining engineering activities of vascular access devices, ensuring products are safe and effective through various engineering processes and collaboration with multi-functional teams.

Health CareHospitalMedicalMedical Device

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

Reports to Manager, Sustaining Engineering

Qualification

Medical device experienceFDA regulations knowledgeDesign Control ProcessRisk AnalysisISO standards knowledgeProficient in Microsoft OfficeData interpretationCommunication skills

Required

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

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)