Senior Preclinical R&D Engineer

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 Preclinical Research & Development (R&D) Engineer supporting the Interventional Cardiology Therapies (ICTx) division. This role will utilize a variety of new and proven technologies to deliver life-changing medical devices to patients and clinicians in support of Boston Scientific's mission. This role supports multiple major product lines, with high visibility, which will provide the right candidate with excellent growth potential. This role will work with various R&D teams within the ICTx division with a primary focus in the Interventional Heart Failure and/or Structural Heart; with a focus on both New Product Development (NPD) and Sustaining Engineering. These investments will drive a robust pipeline for ICTx that will keep Boston Scientific in a market leadership position for many years to come.

 

Responsibilities: Your responsibilities will include:

• Develops/reviews various preclinical test methods, designs, and executes experiments.
• Designs various test methods that may be required in relation to the various challenges associates with new and/or existing innovations.
•  Supports and successfully contributes to project teams through the following activities: product design and development, test of materials, preparation of specifications, process capability studies, research investigations (animal and clinical studies), report preparation, and process/test documentation.
•  Supports solutions to a variety of problems for simple scope and complexity where analysis of situations or data requires a review of identifiable factors.
•  Summarizes, analyzes, and draws conclusions from test results.
•  Assists in troubleshooting on new products/process problems as related to design, materials of construction, or manufacturing processes.
•  Engages with internal company and external contacts. Represents organization on specific projects. Uses diplomacy and tact in interactions and problem solving.
• Trains technicians/operators on new processes and/or test procedures. Supports concepts and designs for new products/processes and submits idea disclosures.
•  Works cooperatively with process development, quality, manufacturing, regulatory, clinical, and marketing on projects of varying complexity to ensure project success.
•  Adheres to internal and external compliance standards, including related testing and documentation.
•  Assists with managing the development projects with internal and external testing facilities.
•  Studies & understands relevant published articles & works for application to company projects and initiatives.
•  Working with project teams to provide detailed instructions for the preparation of the devices for testing.
•  Provides the expertise to aid the R&D team with the selection of materials for existing and new medical devices across the division.
•  Act as the technical liaison for ICTx R&D.

 

Required Qualifications

• Minimum of AS in a medical related field or higher depending on applicable experience.
• Required minimum years of work experience (primarily in medical device or related field): AS, with 15 years of experience 9 years with BS, or 7 years with MS, or 5 years with PhD.
•  Knowledge in preclinical testing over a broad range of medical device products/applications.
•  Understanding of the global regulatory submission requirements/process for medical device submissions.
•  Demonstrated capability to lead high performing technical teams through a structured approach to solving complex technical problems.
•  Personal drive, individual accountability & a strong bias for action.
•  Excellent organizational, communication and collaboration skills.

 

Preferred Qualifications

•  Medical Device industry experience in design controls with a focus on user needs, intended  use, system requirements, system design and traceability.
•  Strong mechanical engineering and problem-solving skills
•  Excellent leadership, organizational, communication, and collaboration skills.
•  Experience working in test labs with fixture design, test set ups, etc.
•  Ability to research literature and