R&D Engineer II

4 weeks ago

Carlsbad, United States Bolt Medical Full time

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 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.

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