R&D Engineer II

DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.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 protocolsreports 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 piles 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 andor 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 requirementsconstraints for mechanical system design is preferred.Experience managing suppliers andor 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.

Created: 2025-02-21