REQUIRED QUALIFICATIONS:

• Bachelor’s degree in Biomedical, Mechanical, Electrical Engineering or equivalent
• 2-4 years related working experience, or equivalent
• Proven track record of leading product development projects from concept to market release, with strong expertise in regulatory compliance and quality management systems (e.g. 21 CFR 820, ISO 13485).
• Experience working within a quality management system and expertise in generating and reviewing engineering documentation (e.g. technical reports, DHF, DMR), in compliance with design controls
• Ability to work independently and within a diverse group of EngineersStrong communication skills (verbal/written) with the ability to present technical data to cross-functional teams and external stakeholders.

PREFERRED QUALIFICATIONS:

• Master’s degree in Biomedical, Mechanical, or Electrical Engineering preferred
• Extensive experience in medical device R&D, with a focus on prototyping, testing, and development of catheter devices
• Expertise in industry standards and regulations (e.g. ISO, ASTM, ASME, IEC, etc.) and their application in medical device design and development
• Experience with product lifecycle management
• Experience with injection molding component design
• Experience with electrical medical device testing and development

ABOUT THE ROLE:

This role is in the R&D Engineering team of the Access Solutions division. This group is responsible for managing the complete lifecycle of products from ideation to market release and beyond. The group also serves new product development projects through concept generation, design, prototyping, and manufacturing transfer. The engineer will work within a team of other engineers and cross-functional teams to compile, analyze, and report operational, test, and research data to establish performance standards for newly designed or modified products, processes, and materials. In addition, the engineer will have an opportunity to work with the appropriate government bodies to obtain regulatory approval, and to issue patents in conjunction with the IP department.
At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model, requiring employees to be in our local office at least three days per week. Relocation assistance is not available for this position at this time. Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time.

YOUR RESPONSIBILITIES WILL INCLUDE:

• Fully participate in project teams to contribute the necessary technical work related to product design and development.
• Mentor junior engineers and provide technical leadership within the project team, fostering a collaborative and innovative environment.
• Collaborate closely with manufacturing, process engineering, supplier engineering, and customer support teams to ensure seamless product development.
• Gather requirements from internal and external sources to accurately capture user needs and ensure products are meeting them.
• Perform in-depth technical analysis, root cause investigations, and failure mode assessments for both new and existing products.
• Generate and review detailed engineering documentation (e.g. technical reports, DHF, DMR) and ensure compliance with quality systems and regulatory requirements.
• Drive and support Design for Manufacturing (DFM) activities, identifying opportunities for process optimization and cost reduction.
• Ensure compliance with company health and safety policies and proactively address unsafe working conditions.
• Other duties as required, including leading continuous improvement initiatives.