R&D Eng - P4

Sr. Electrical Engineer

We have an exciting opportunity for a Sr. Electrical Engineer focusing on Sustaining activities related to the recent acquisition of Bolt Medical in Carlsbad, CA. This is a unique opportunity to work on cutting-edge technology and make a significant impact on patient care and clinical outcomes within the Interventional Cardiology division here at Boston Scientific.

Your responsibilities:

• Lead Sustaining activities such as Design Change Analyses (DCA's) for Capital Equipment – mainly focusing on Electrical changes.
• Willingness to travel to Bolt Medical in Carlsbad, CA to meet the team and learn the product, as needed.
• Learn both BSC and Bolt quality systems and work with the acquisition integration team to assess when and how to design changes such that compliance is always maintained.
• Collaborate with cross-functional teams, including R&D, Quality, Regulatory, Operations, Supplier Engineering, Sourcing, Supply Chain, Labeling, Packaging, and others as necessary to facilitate design changes.
• Ensure compliance with relevant medical device regulations and standards, including IEC 60601-1, 60601-1-2, and other applicable safety standards.
• Create and maintain detailed technical documentation, including DCA's, ECAD, BOM structures, Design Outputs, protocols, reports, and other applicable documents that will be stored in Windchill.
• Train and/or provide work direction to Technicians, Interns, and other Engineers as necessary
• Provide clear and effective communication to stakeholders, including senior leadership, regarding project status, risks, and mitigation strategies.
• Present technical findings and recommendations at cross-functional meetings and persuade stakeholders to agree on proposed approaches.
• Drive organizational collaboration, helping make impactful decisions that drive organizational success within both BSC and Bolt Medical throughout the acquisition process.
• Apply business and industry best practices and knowledge of internal/external business challenges to improve products, processes, or services.
• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to all documented quality processes and procedures

Minimum Qualifications:

• Bachelor's or Master's degree in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or a related field.
• Minimum of 5 years of experience in R&D, with a focus on medical device design.
• Previous ECAD and medical device Sustaining Engineering experience needed.
• Strong communication and presentation skills, with the ability to convey complex technical concepts to non-technical stakeholders.

Preferred Qualifications:

• Previous documentation control (e.g. – Windchill), along with Non-Conformance (NCEP) and CAPA experience.
• Previous medical device integration and acquisition experience (or similarly regulated field) is a major plus.
• Altium and Solid Works experience would be very useful.
• Strong technical background in medical electrical projects, including architectural design and compliance with medical safety standards like IEC 60601-1 and IEC 60601-1-2.

Excellent problem-solving skills and the ability to make data-driven decisions.