Boston Scientific R&D Engineer III 

Canada, Ontario, Mississauga 

667425002

Your Responsibilities will include:

• Investigate product complaints at clinical/customer sites, perform root cause analysis of failures, and propose remediation in a timely fashion
• Analyze complaint data and generate prioritized actions to address shortcomings associated with the company’s products
• Review existing product design, identify weaknesses, propose, implement, and monitor effectiveness of improvements.
• Analyze mechanical designs
• Create strategy for the verification of the corrective designs, and participate in verification activities.
• Work with suppliers, supply chain and process engineering on value improvement projects or products.
• Produce and revise DHF and DMR documentation as needed
• Contribute to risk management content such as FMEA, PFMEA and hazard analysis
• Responsible for technical input into project level planning.
• Provide technical guidance to review work plans and advise on unusual features of projects
• Perform all duties in compliance with the quality management system; actively contribute to the continuous improvement projects.
• 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.
• Support cross functional team in Post Market Surveillance activities.
• Support the development of intellectual property where required.
• Support regulatory filings to various government bodies
• Respond to field Requests
• Other duties as required

Required Qualifications:

• Mechanical/Biomedical Engineering degree required with a focus on biomedical experience
• 4+ years of related working experience from a regulated manufacturing industry
• 3+ years of relevant design control experience

Preferred Qualifications

• Experience with guidewire and catheter devices development.
• Knowledge of ISO 13485, ISO 14971, 21 CFR part 820, ISO 11135 and ISO 11607
• Experience with drafting and maintaining DHF and DMR documentations
• Experience with leading rapid design iteration and making design recommendations
• Ability to independently develops and adapts work plans based on vague or changing project goals
• Strong hypothesis-driven experimental design and statistical analysis skills
• Candidates should be self-starters and have a hands-on approach
• Ability to work independently and within a diverse group of Engineers and Production staff
• Strong communication skills (verbal/written) and demonstrated leadership skills
• Possess a strong interest in biomedical technology
• 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

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

Compensation foris governed by Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives).