Senior R&D Engineer - Sustaining

Additional Location(s):  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.           

 

About the role:

We have an exciting opportunity for a Senior R&D Engineer focusing on Sustaining activities. 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.

 

Work Mode:
At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model, requiring employees to be in our Maple Grove, MN office at least three days per week.

 

Your responsibilities will include:

• 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, demonstrates 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.

 

Requisition ID: 618933 

Minimum Salary: $ 82600 

Maximum Salary: $ 156900 

 

The anticipated compensation listed above and the value of core and op