דרושים Principal Process Engineer - Electrophysiology ב-Boston Scientific ב-Canada, Mississauga

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).

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:

• 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 (Biomedical, Mechanical 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

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).

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 (Biomedical, Mechanical 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

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:

• Work within a cross-functional team to identify and implement effective controls and support product development through commercialization.
• Responsible for design control, risk management & Usability of next-generation capital equipment, Ultrasound Imaging devices.
• Uses clinical knowledge to influence how devices they are working on are tested and designed
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Independently, or as a member of a team, develops, directs, and executes plans for design control and risk management of complex projects
• Leads the implementation and development of product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs)
• Adds to and promotes the culture of quality-centric patient care and customer satisfaction within the New Product Development team
• Promotes and influences compliance to BSC’s quality, business systems & Industry regulations
• Provides quality input (SME and/or independent reviewer) as required, at defined project/product/process milestones (e.g., design reviews, project design plans, design/process changes to existing product lines).
• Other duties as required.

Required qualifications:

• Bachelor's Degree in Engineering (Electrical Engineering, Systems Engineering, Biomedical)
• 5+ years of relevant work experience
• Knowledge of Ultrasound imaging devices & IEC 60601-2-37
• Knowledge of ISO 13485, ISO 14971, IEC 62366-1
• Experience with design controls, design inputs and outputs, and risk mitigation activities
• Experience with systems and electrical/software design and test experience with IEC 60601-1 and collateral standards
• Excellent analytical and communication skills (written and oral)
• Excellent organization and time management skills
• Interest in biomedical or health-related industry

Preferred qualifications:

• 2+ years of experience in a Design Assurance role
• 5+ years of experience in the medical device industry

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 include:

• Fully participate in project teams to contribute the necessary technical work related to product design and development.
• Technical analysis of medical device systems and materials for existing products to ensure designs meet quality and regulatory standards.
• Assist in DFM (Design for Manufacturing) activities and work cross-functionally with Quality, Sourcing and Process/Manufacturing counterparts.
• Investigate failure modes and perform root cause analyses
• Generate detailed engineering documentation (e.g. Technical reports, DHF, and DMR) in adherence to quality policies and systems.
• Conducts planning for broad, technical projects by applying mature engineering knowledge, and soliciting input from other stakeholders as appropriate.
• Comply with the Health & Safety policies of the company and inform Management of unsafe working conditions.
• Other duties as required.

Required qualifications:

• Bachelor’s degree in Mechanical/Biomedical engineering, or equivalent
• Minimum of 4 years related working experience, or equivalent
• Experience working within a quality management system and quality system controls (e.g. Design inputs/outputs, Verification/validation, etc.)
• Experience with design requirements for medical devices as per 21 CFR 820 and ISO 13485.
• Knowledge of medical device risk management and ISO 14971.
• Candidates should be self-starters and have a hands-on approach
• Ability to work independently and within a diverse group of Engineers
• Strong communication skills (verbal/written)

Preferred qualifications:

• Bachelor’s degree in Biomedical, Mechanical, or Electrical Engineering preferred
• Experience working within medical device industry
• Familiarity with industry-related standards (e.g. ISO, ASTM, ASME, IEC, etc.) and their direct application
• Experience with product lifecycle management
• Experience with catheter devices development
• Experience with injection molding component design

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).