R&D Eng - P4

About the role

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.

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, demonstrate a primary commitment to patient safety and product quality by maintaining compliance to all documented quality processes and procedures.

Requirements

• 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).
• 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.

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.

Benefits

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.

Schedule

This position will follow an onsite schedule, requiring 3 days in-office per week from our Carlsbad, CA or Maple Grove, MN or Arden, Hill MN site.

Pay

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.