Principal R&D Engineer - Electrophysiology

Boston Scientific - Arden Hills, MN

Full-time - Principal

Arden Hills, MN

Miscellaneous Manufacturing

About the position

The Ablation Catheter Development Team at Boston Scientific is expanding and is seeking a Principal Engineer to support the development of electrophysiology products within the Cardiology division. This role is pivotal as electrophysiology is a significant growth area for the company, particularly following the acquisition of FARAPULSE Inc., which enhances Boston Scientific's leadership in Personalized EP Solutions, focusing on Atrial Fibrillation. As a Principal Engineer, you will be integral to the team, providing mechanical engineering support in the creation and development of innovative electrophysiology ablation catheter technologies. In this position, you will engage with new product development teams to address complex customer issues through applied problem-solving skills. You will be part of a high-performance team responsible for the design, implementation, and testing of disposable medical devices within the electrophysiology pulsed field ablation single-use device portfolio. This role demands adherence to best-in-class development practices and a holistic approach to product design, collaborating with both internal and external partners. Your responsibilities will include researching, developing, designing, and evaluating mechanical and electro-mechanical materials, components, assemblies, processes, and equipment. You will tackle diverse engineering problems of high complexity, utilizing creativity and ingenuity to develop effective solutions. Additionally, you will drive the technical aspects of complex single-use device development, including requirements gathering, design, implementation, testing, integration, transfer to manufacturing, and verification/validation processes. You will also lead technical teams through problem-solving initiatives, ensuring quality system compliance for medical device development and championing continuous improvement practices. As a leader, you will foster a strong team culture centered around high expectations and performance, while also participating in the development of team members through training and feedback. You will maintain detailed documentation throughout all phases of research and development and provide clear communication to stakeholders during key technical updates.

Responsibilities

• Researches, develops, designs, and evaluates mechanical and electro-mechanical materials, components, assemblies, processes and/or equipment.
• Develops solutions to diverse engineering problems of high complexity which require the regular use of ingenuity and creativity.
• Drives technical aspects of complex single-use device development including requirements, design, implementation, test, integration, transfer to manufacturing, and verification/validation.
• Solves system problems by analyzing the situation and recommending corrective or alternative actions.
• Leads technical teams through problem solving and facilitates decision making around key technical issues.
• Plans and organizes project assignments of substantial variety and complexity, directing support personnel and project activities.
• Ensures quality system compliance for medical device development, champions continuous improvement, and adopts best practices.
• Participates in the development of others by facilitating training and providing feedback and guidance.
• Creates a strong team culture around high expectations and high performance.
• Writes and submits intellectual property (patents).
• Maintains detailed documentation throughout all phases of research and development.
• Provides clear communication to stakeholders at key technical updates.

Requirements

• BS degree in Mechanical Engineering.
• 7+ years of work experience in medical device or related field with a BS degree, or 5+ years with a relevant advanced degree.
• Experience managing technical aspects of projects as a member of a cross-functional core team.
• Demonstrated strong cross-functional collaboration and project/task management skills.
• Passion for understanding and solving problems for end users.
• Strong written and oral communication skills.

Nice-to-haves

• Proven self-starter who addresses critical issues and ambiguous requirements effectively.
• Experience with electrophysiology and/or Class II or Class III Medical Device product development.
• Demonstrated product development leadership and communication skills.
• Ability to provide technical leadership on large-scale development programs.
• Systems engineering mindset, able to articulate customer unmet needs and translate into holistic technical solutions.
• Understanding of working within a quality system, IEC and ISO standards relevant to medical device lifecycle and risk management (i.e., ISO 13485).

Benefits

• Access to the latest tools, information, and training to advance skills and career.
• Support for progressing in career ambitions.
• Diverse and high-performing teams tackling important health industry challenges.