דרושים Principal Mechanical Designer ב-Boston Scientific ב-Canada, Mississauga

About this role:

The Principal Regulatory Specialist will support regulatory activities for the Access Solutions Franchise within the Electrophysiology division. In this role, you will develop and implement regulatory strategies to support product development, approvals, and ongoing regulatory compliance. You will collaborate closely with cross functional teams to influence and drive decisions that align with business objectives and regulatory requirements. The position requires strong leadership, communication and strategic thinking to ensure regulatory success in a dynamic and fast paced environment.

Your responsibilities will include:

• Develops and implements regulatory strategies for new and modified products
• Acts as a core member on new product development and sustaining teams, providing regulatory feedback and guidance throughout the product and manufacturing process development cycle, and coordinating team inputs for submissions
• Prepares and submits regulatory applications, as well as internal regulatory file documentation
• Reviews product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
• Provides guidance to other team members during strategy formulation, submission preparation and interaction with regulatory bodies
• Supports international regulatory partners with commercial marketing applications
• Supports efforts to continuously improve department and divisional quality, including collaboration, best practices, and knowledge sharing
• Supports external audits and maintain audit readiness

Required Qualifications:

• Minimum of a Bachelor's Degree in a scientific or technical discipline
• Minimum of 7 years of experience in the medical device industry, or 5 years’ experience with an advanced degree (Master’s or PhD)
• Demonstrated proficiency with relevant US/EU regulatory requirements for medical devices including Quality Systems standards
• Demonstrated experience authoring/supporting a variety of regulatory submissions
• Demonstrated ability to effectively lead multiple regulatory projects and priorities
• Excellent written and oral communication, technical writing, and editing skills
• Ability to articulate complex ideas clearly both verbally and in writing
• Ability to work independently with minimal supervision, as well as mentor/guide others

Preferred Qualifications:

• Demonstrated leadership, strategic thinking, project planning, and project management skills
• Understanding of product development process and design controls
• Familiarity with international regulatory requirements
• Excellent organizational, communication and collaboration skills. Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources

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).

Your responsibilities will include:

• Conduct mechanical design activities for developing complex cutting-edge medical device systems through prototyping, testing and modeling.
• Conduct simulation and modeling activities using tools such as FEA and CFD to predict mechanical performance and optimize design parameters
• Develop and validate computational models of mechanical systems using tools such as MATLAB or SolidWorks Simulation
• Perform independent tests, studies, analyses, and interpretations to generate technical conclusions and provide recommendations.
• Assist in DFM (Design for Manufacturing) activities.
• 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.
• Conduct work across the full scope of technical and documentation activities for the department.
• 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.
• 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 mechanical or biomedical engineering
• 3+ 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
• Experience with leading rapid design iteration and making design recommendations
• Strong hypothesis-driven experimental design and statistical analysis skills

Preferred Qualifications

• Experience focusing on R&D activities in the medical devices industry
• 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

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).

• Conducting detailed engineering assessments and designing fixturing systems for medical device manufacturing processes.
• Utilizing complex software tools (SolidWorks, Capture, PDM, and Windchill) to create technical designs that meet mechanical specifications for fixturing, tooling, and automation equipment.
• Using SolidWorks for design, including Simulation (FEA), to verify designs meet functional, structural, and performance requirements.
• Selecting appropriate materials for fixturing based on material properties, ensuring compatibility with medical device manufacturing processes.
• Applying structured problem-solving, lean principles, and best practice process development to enhance product and process efficiency.
• Designing and integrating mechanical and electro-mechanical systems, including components such as pneumatic actuators, grippers, motors, cameras/machine vision, and safety systems, to optimize fixturing for medical devices (strong controls knowledge).
• Leading and executing structured experimental plans to drive data-based decisions and validate designs.
• Performing critical engineering calculations such as speed, torque, load, stress, tolerance stack-up analysis, and force to ensure fixturing meets design requirements.
• Presenting technical data and design recommendations to key stakeholders in both formal and informal settings.
• Collaborating closely with SMEs and cross-functional teams to align fixturing solutions with manufacturing capabilities and medical device specifications.
• Providing mentorship and work direction to technicians and entry-level engineers on mechanical design and fixturing.
• Independently managing projects, meeting timelines, and documenting proof concepts with supporting data.
• Actively engaging in the design, fabrication, and assembly of fixturing, ensuring it meets functional requirements and integrates seamlessly with mechanical and electro-mechanical systems.
• Demonstrating strong communication skills to facilitate the design process and project completion.
• Ensuring compliance with the company’s Quality Management System, adhering to applicable standards, regulations, and procedures.
• Occasionally traveling as required to collaborate with teams, support equipment setup, and ensure design implementation.
• Performing other duties as needed to support team goals and business objectives.

• Bachelor’s degree in Mechanical Engineering.
• 9+ years of relevant mechanical design experience, particularly in designing fixturing, molding, and automation equipment for manufacturing processes.
• Proficiency in SolidWorks, with substantial experience in both design and simulation (FEA) for fixturing, tooling, and automation systems.
• Solid understanding of GD&T (Geometric Dimensioning and Tolerancing) and its application in mechanical design.
• Strong problem-solving skills and experience in root cause analysis to drive design improvements.
• Experience with experimental design, data analysis, and statistical methods to support engineering decisions.
• Excellent communication, organizational, and collaboration skills, with the ability to work independently and with a team.

• Work experience in the medical device industry, particularly with designing fixturing and tooling for medical device manufacturing.

Please note that if you are selected to advance in our recruitment process, you will be contacted to submit a design portfolio or CAD submission that showcases your mechanical design skills. This will help us assess your expertise and creativity in this field. Please ensure that your submission does not include any confidential or proprietary information from previous or current employers.

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).