R&D Engineer II
2 months 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 an engineer in this team, you will work collaboratively with other 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 to project teams to provide technical work related to product design and development.
- Analyze medical device systems and materials for new product development and existing products to ensure designs meet quality and regulatory standards.
- Gather requirements from internal and external sources to accurately capture user needs and ensure products meet them.
- Investigate failure modes and perform root cause analyses.
- Generate detailed engineering documentation in adherence to quality policies and systems.
- Innovate and create new concepts and designs for products and submit invention disclosures.
- Assist in Design for Manufacturing (DFM) activities.
- Comply with health and safety policies and inform management of unsafe working conditions.
Required Qualifications:
- Bachelor's degree in Biomedical Engineering or equivalent.
- Minimum 2 years 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-starters with a hands-on approach.
- Ability to work independently and within a diverse group of Engineers.
- Strong communication skills (verbal/written).
Preferred Qualifications:
- Bachelor's degree in Biomedical, Mechanical, or Electrical Engineering preferred.
- 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.
- Experience with catheter devices development.
- Experience with injection molding component design.
- Experience with electrical medical device testing and development.
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