Senior R&D Engineer - Sustaining

Senior R&D Engineer - Sustaining

We have an exciting opportunity for a Senior R&D 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.

This role requires a temporary relocation to Carlsbad, CA for a period of 6 to 12 months. Boston Scientific will provide support for relocation and temporary living expenses. At the conclusion of the temporary assignment, the role will be returned to Maple Grove, MN. Please apply only if you're comfortable with this arrangement.

Your responsibilities will include:

• 612-month assignment on-site at Bolt Medical in Carlsbad, CA to meet the team and learn the product, with the option to return to Maple Grove, MN once appropriate.
• Lead Sustaining activities such as Design Change Analyses (DCA's) for Capital Equipment (i.e. console, cart, electrical, mechanical, software, and firmware).
• 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, BOM structures, Design Outputs, protocols, reports, and other applicable documents that will be stored in Windchill.
• Train and/or provide work directions to Technicians, Interns, and other Engineers as necessary (will involve hiring additional Sustaining engineers in the coming years).
• 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.
• Applying business and industry best practices and knowledge of internal/external business challenges to improve products, processes, or services.
• In all actions, demonstrate a primary commitment to patient safety and product quality by maintaining compliance to all documented quality processes and procedures.

Required 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 medical device Sustaining Engineering experience needed (we are looking for someone to lead this effort i.e. "Self-Starter").
• 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 SolidWorks 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.