R&D Engineer III - Electrophysiology

Additional Location(s): Canada-ON-Mississauga

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

The R&D Engineer III will join our Access Solutions Site to lead the development of our next generation steerable sheath for the franchise. This role will develop new technology, products, equipment, and processes with minimal supervision. Furthermore, they will compile and analyze operational, test, and research data to establish technical specifications for designing or modifying products, processes, and materials.

Your responsibilities will include:

• Support complex cutting-edge medical device systems through prototyping, testing and modeling.
• Develop device design history files (i.e., requirements, risk management, usability files.
• Ensure compliance to industry and international standards.
• Develop verification and validation plans, protocols, and reports.
• Perform independent tests, studies, analyses, and interpretations to generate technical conclusions and provide recommendations.
• Conduct work across the full scope of technical and documentation activities for the department.
• Make independent studies, analyses, interpretations, and conclusions.
• Responsible for technical input into project level planning. 
• Provide technical guidance to review work plans and advise on unusual features of projects
• Provide technical, project level leadership to engineering assistants or junior engineering staff.
• Participate in failure investigations and repair planning.
• Assist in DFM (Design for Manufacturing) activities.
• Develop and test new manufacturing processes.
• Support regulatory filings to various government bodies as required.
• Support the development of intellectual property where required.
• Support pre-clinical and clinical research activities​ where required.
• Other duties as required.

Required Qualifications

• Bachelor's Degree in Engineering (Electrical, Biomedical preferred)
• 4+ years of related working experience from a regulated manufacturing industry
• 3+ years of relevant design control experience
• Experience with the overall design and development process

Preferred Qualifications

• Knowledge of ISO 13485, ISO 14971, 21 CFR part 820, ISO 11135 and ISO 11607
• Self-starter with the ability to quickly learn about new processes
• Excellent analytical and communication skills (both written and oral)
• Able to work independently and in a multidisciplinary team environment

About the role 

We are seeking a Senior R&D Engineer to join our dynamic R&D Packaging and Sellable Product team. As a Senior R&D Engineer, you will be responsible for leading the design, development and implementation of packaging solutions for our products in addition to working closely with cross-functional teams, i.e. Marketing, Regulatory and Supply Chain, etc., to develop strategies for successful product commercialization.

Your responsibilities will include: 

• Lead various packaging design projects in support of new product development and continuous improvement initiatives
• Develop packaging specifications based on collected Voice of Customer (VOCs), business requirements and regulatory standards
• Utilize CAD software and prototyping techniques to create and iterate packaging designs
• Evaluate new packaging designs through testing to ensure compliance with performance metrics
• Create DHF and DMR documentation to capture design control and risk management activities for packaging development
• Collaborate cross-functionally with various departments to develop strategies for streamline regulatory approval and commercialization of products in various jurisdictions
• Independently plan and coordinate activities to meet project timelines and deliverables
• Provide technical leadership and coaching for junior engineers on the team
• Support investigations, as needed, for packaging-related non-conformances and CAPAs (Corrective and Preventative Actions)  
• Other duties as required

Required qualifications: 

• Bachelor’s degree in Packaging Engineering, Mechanical Engineering, or a related field

• 5+ years of experience in packaging engineering, preferably within the medical device industry 
• Proficiency in CAD software (e.g., SolidWorks) and packaging design tools
• Strong knowledge of packaging materials, processes and manufacturing methods
• Familiarity with packaging testing standards (e.g., ISTA 3A, ASTM D4169)
• Strong analytical and problem-solving abilities
• Excellent interpersonal and communication skills (verbal/ written)

Preferred qualifications: 

• Familiarity with the design control process per ISO 13485
  • Excellent project management skills with the ability to prioritize and manage multiple projects simultaneously

Learn more about our Transseptal Access Devices

Click this link to explore the groundbreaking technology behind our transseptal access devices at Boston Scientific: Transseptal access devices

Requisition ID: 586656

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.