Boston Scientific Principal R&D Engineer Materials 

United States, Minnesota 

433960946

About the role:

Independently conducts development work as part of a major research and/or development projects related to Interventional Cardiology Therapies (ICTx). Receives minimal technical direction/review on broad scope or complex projects related to biomedical engineering and/or related technologies.

Your responsibilities will include:

• Supports 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, 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.
• 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 aids with the fabrication of tooling and fixtures.
• Adheres to internal and external compliance standards, including related testing and documentation.
• 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.
• 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.
• Some travel maybe required, expected less than10%

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): 5 years with BS, 3 years with MS or PhD.
• Knowledge in materials sciences, biomedical engineering, mechanical engineering, 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.

Preferred qualifications:

• Personal drive, individual accountability & a strong bias for action.
• Excellent organizational, communication and collaboration skills.
• Strong mechanical engineering and problem-solving 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).

Maximum Salary: $ 188300

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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.

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