Associate Sr. R&D Fellow 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 an Associate Senior Research & Development (R&D) Fellow 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, including Percutaneous Coronary Intervention Guidance (PCIG), Atherectomy, 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.

Your responsibilities will include:

• Develops test methods, designs, and executes experiments, and prototypes for 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.
• Assist with drawings, BOM’s, and prepares standard reports/documentation.
• 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.
• Translates customer needs into product requirements and design specifications.
• Trains technicians/operators on new processes and/or test procedures. Supports concepts and designs for new products/processes and submits idea disclosures.
• Applies the Technical Development Process (TDP)/Product Development Process (PDP) methodologies.
• Works cooperatively with process development, quality, manufacturing, regulatory, clinical, and marketing on projects of varying complexity to ensure project success.  
• Assists the R&D teams with designs, procures, and fabricates tooling and fixtures.
• Adheres to internal and external compliance standards, including related testing and documentation.
• Identifies areas for improvement, suggests solutions, and submits idea records.
• Collaborating with a diverse set of cross functional stakeholders and global groups to define strategy for product material design and testing including processing aids, coatings, sterilization methods and in vivo and in vitro test methods.
• Identifies and evaluates new materials or technologies for application to products.
• 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.
• Assisting with project tracking, meeting with our various team members to gather important information/dates regarding project milestones.
• 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.
• 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:

• BS or higher in Biomedical Engineering, Materials Science, or related engineering degrees and/or BS or higher in chemistry, biology, or related biomedical related degree.
• Required minimum years of work experience (primarily in medical device or related field): 9 years with BS, or 7 years with MS, or 5 years with PhD.
• Knowledge in materials sciences, biocompatibility, sterilization, and 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 develop clinical understanding.
• Familiar with international standards (IEC, ISO 10993, EN, AAMI, etc.).
• Familiar with Regulated Materials (RoHS, WEEE, REACH).
• Familiar with EPA standards (specifically PFAS regulations).

Requisition ID: 582527

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement.  The goal of the drug testing is to increase workplace safety in compliance with the applicable law.  

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.