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RECRUITERS: DO NOT CONTACT.

Responsibilities:

Overview:

The R&D Engineer will use engineering knowledge to design, develop, verify and validate product designs in support of company’s strategic plan. Contribute as part of a cross-functional team in product design and development, process development and optimization, and verification & validation testing to support product transfer to manufacturing.

Responsibilities:

• Prepare documentation to support quality system for design functions (project plans, concept document, FMEA, design input, test results, drawings, etc.)
• Prepare technical documentation, including manufacturing instructions, test methods, drawings, BOMs, protocols, and reports to support design control activities.
• Perform Verification and Validation (V&V) and may draft protocols/reports for approval.
• Work with engineers & QA to create new components, assemblies, or tools.
• Conducts testing to verify that the design meets the engineering specifications.
• Document engineering work in compliance with the company's quality system.
• Identifies hazards and mitigates risk associated with identified hazards in Design and Process FMEA. Assess failure modes and conduct technical risk analysis.
• Compiles and analyzes data, identifies causes, draws conclusions, generates reports.
• Provide hands-on, technical execution in the prototyping and development of devices.
• Manages processes and ensures that activity goals are achieved.
• Training and/or providing work direction to technicians and less experienced engineers.
• Support the development of specifications for tooling and fixturing according to company quality standards.

Qualifications:

Education & Experience:

• Engineering degree desired or equivalent experience in related job field.
• 2+ yrs Biomedical product or medical device development experience (catheter experience desirable).
• Working knowledge of mechanical design principles and FDA regulated medical device design controls a plus.
• Proficient in CAD software, preferably SolidWorks.
• Familiarity with statistical analysis of raw data is required, proficiency in Minitab is preferred.
• Understanding of IEC60601 requirements/constraints for mechanical system design is preferred.
• Experience managing suppliers and/or contract manufacturers a plus.
• Hands-on mechanical prototyping, verification, and failure analysis skills.
• Familiarity with design control according to 21 CFR 820 or ISO 13485, engineering change orders (ECO), Corrective Actions and Preventive Actions (CAPA) preferred.

Skills & Abilities:

• Proficient in Risk Management according to ISO 14971.
• Knowledge of ASME Y14.5 GD&T.
• Excellent interpersonal, communication, and documentation skills are required.
• Proven self-starter who runs towards critical issues, ambiguous requirements, or loosely defined challenges with a demonstrated ability to rally teams to achieve business results.
• Takes initiative and acts quickly to drive solutions.
• Strong interpersonal, organizational and communication skills.
• A flexible team player, focusing on shared goals with a positive results-oriented attitude.