R&D Engineer II
21 hours ago
About the Role:
This position is part of the R&D Engineering team within the Access Solutions division at Boston Scientific. The team is responsible for new product development projects, from concept generation to manufacturing transfer. As a key member of this team, you will work collaboratively with engineers and supporting departments to analyze and report operational, test, and research data to establish performance standards for newly designed or modified products, processes, and materials.
Your Responsibilities:
- Contribute technical expertise to project teams to ensure product design and development meet quality and regulatory standards.
- Analyze medical device systems and materials to identify areas for improvement and ensure compliance with quality and regulatory requirements.
- Collaborate with internal and external stakeholders to gather requirements and ensure products meet user needs.
- Investigate failure modes and perform root cause analyses to drive continuous improvement.
- Develop detailed engineering documentation, including technical reports, design history files, and design and manufacturing records.
- Develop innovative concepts and designs for products and submit invention disclosures.
- Support Design for Manufacturing (DFM) activities to ensure efficient and cost-effective production.
- Ensure compliance with health and safety policies and report any unsafe working conditions.
Required Qualifications:
- Bachelor's degree in Biomedical Engineering or equivalent.
- Minimum 2 years of related working experience or equivalent.
- Experience working within a quality management system and quality system controls.
- Knowledge of design requirements as per 21 CFR 820 and ISO 13485.
- Self-starter with a hands-on approach and strong communication skills.
Preferred Qualifications:
- Bachelor's degree in Biomedical, Mechanical, or Electrical Engineering.
- Experience working within medical device R&D departments with hands-on prototyping and testing.
- Knowledge of ultrasound imaging, particularly in cardiac applications.
- Familiarity with industry-related standards and their direct application.
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