Senior R&D Engineer
4 days ago
We are seeking a highly skilled and motivated Senior R&D Engineer to join our team at Boston Scientific. As a key member of our Peripheral Interventions Division, you will be responsible for sustaining technology, products, materials, processes, or equipment of moderate complexity.
Key Responsibilities- Contribute to project teams, including sustaining engineering, design change strategy, test of materials, preparation of specifications, process capability studies, research investigations, report preparation, and test documentation.
- Lead design change to ensure proposed changes are systematically and thoroughly analyzed to verify that the design intent is still met.
- Maintain product performance through support of Quality Investigations.
- Work independently to plan and schedule own activities necessary to meet timelines.
- Design and coordinate standard engineering tests and experiments.
- Design, procure, and fabricate tooling and fixtures.
- Perform troubleshooting on products/process problems as related to design, material, or process.
- Summarize, analyze, and draw conclusions from test results.
- Prepare standard reports/documentation to communicate results to the technical community.
- Responsible for engineering documentation.
- Invent/create concepts and designs for new products/processes and submit idea disclosures.
- May train and/or provide work direction to technicians.
- Work cross-functionally with project management, quality, manufacturing, regulatory, clinical, and marketing to ensure project success.
- Support integration of newly acquired technologies into Boston Scientific.
- Demonstrate design control knowledge through generation of high-quality deliverables.
- BS (or more) in Biomedical Engineering or Mechanical Engineering from an accredited institution.
- 5+ years related engineering experience in the medical device industry.
- Proven ability to work within a regulated industry environment and with a track record of accomplishments.
- Product development experience a plus.
- A driven individual with the ability to work with a cross-functional group or independently to plan, schedule, and execute activities necessary to meet project timelines.
- Fundamental understanding of design controls and risk management within the medical device industry.
- Fundamental understanding of the Quality System per ISO 13485 or 21 CFR 820.
- Biomedical or anatomy experience and/or aptitude.
- Medical device product development system knowledge (PDP/TDP).
- Effective communication skills required due to support of cross-functional projects within a team.
- Experience working with cross-cultural teams.
- Technical Project Management experience.
- Systems engineering and electromechanical equipment sustaining/development experience a plus.
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures.
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