R&D Engineer III

Boston Scientific; Mississauga; On-site; USD 66,000 - 132,000; Full time

Job summary

A leading company in the health industry is seeking a Research & Development Engineer III to lead product lifecycle activities for their transseptal portfolio. The role involves complaint analysis, collaboration with cross-functional teams, and contributions to new product development. Candidates should have a strong background in mechanical or biomedical engineering, along with experience in regulated environments. Join a dynamic team focused on innovative medical solutions.

Qualifications

• At least 4 years of experience in a regulated manufacturing environment.
• Minimum of 3 years in design control processes.

Responsibilities

• Investigate product complaints and perform root cause analysis.
• Collaborate with suppliers and engineering teams on value improvement projects.
• Support Post Market Surveillance activities and regulatory filings.

Skills

Communication

Leadership

Statistical Analysis

Education

Bachelor's degree in Mechanical or Biomedical Engineering

Tools

ISO 13485

ISO 14971

21 CFR part 820

ISO 11135

ISO 11607

Job description

Additional Locations:

Canada-ON-Mississauga

Our Values

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we offer opportunities to work with diverse, high-performing teams on significant health industry challenges. With access to the latest tools, training, and information, we support your career growth and ambitions.

About the Role

Our Research & Development Engineer III will join our Access Solutions Franchise, leading product lifecycle activities for our transseptal portfolio. Responsibilities include continuous improvement, complaint analysis, testing, training, and collaboration with suppliers and cross-functional teams. The role offers the chance to participate in new product development in a fast-paced, collaborative environment.

Your Responsibilities

1. Investigate product complaints, perform root cause analysis, and propose timely solutions.
2. Analyze complaint data and prioritize actions to address product issues.
3. Review product designs, identify weaknesses, and implement improvements.
4. Analyze mechanical designs and develop verification strategies.
5. Collaborate with suppliers and engineering teams on value improvement projects.
6. Maintain DHF and DMR documentation as needed.
7. Contribute to risk management activities such as FMEA and hazard analysis.
8. Provide technical input for project planning and review work plans.
9. Guide and support engineering staff and cross-functional teams.
10. Support Post Market Surveillance activities and regulatory filings.
11. Respond to field requests and perform other duties as required.

Required Qualifications

• Bachelor's degree in Mechanical or Biomedical Engineering with biomedical focus.
• At least 4 years of experience in a regulated manufacturing environment.
• Minimum of 3 years in design control processes.

Preferred Qualifications

• Experience with guidewire and catheter device development.
• Knowledge of ISO 13485, ISO 14971, 21 CFR part 820, ISO 11135, ISO 11607.
• Experience drafting and maintaining DHF and DMR documents.
• Experience leading rapid design iterations and making design recommendations.
• Ability to develop and adapt work plans independently.
• Strong experimental design and statistical analysis skills.
• Self-motivated with a hands-on approach.
• Excellent communication and leadership skills.
• Interest in biomedical technology and quick learner.
• Ability to work independently and in multidisciplinary teams.

Learn More

Explore our transseptal access devices: Transseptal access devices.

#LI-RT

Compensation

Requisition ID: 602368

Salary Range: $66,500 - $131,800. Actual compensation varies based on location, experience, and other factors. Benefits details are available at www.bscbenefitsconnect.com.

Additional compensation details depend on role type, including bonuses and incentives.

Our Mission

We are committed to advancing science for life through innovative medical solutions that improve patient outcomes, create value, and support our communities. Join us if you're a problem-solver with the spirit to make a difference worldwide!