Job Description Summary

Job Description

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.

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.
• Responsible for ensuring products are safe and effective by developing test methods, executing device evaluations, interpreting data results, and presenting findings to management.
• Develops/update technical 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 cross 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.

Qualifications:
• 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).

Required Skills

Optional Skills

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