דרושים Sterilization Scientist Iii ב-Boston Scientific ב-Canada, Mississauga

Your responsibilities will include:

• Fully participating in project teams to contribute the necessary technical work related to packaging and product design and development
• Technical analysis of medical device packaging systems and materials for new product development and existing products to ensure designs meet quality and regulatory standards
• Gather requirements from internal and external sources to accurately capture user needs and ensure products are meeting them
• Investigate field related issues and perform root cause analysis
• Generate engineering documentation (e.g., DHF and DMR) in adherence to quality policies and systems.
• May lead packaging specific initiatives to support new designs, materials, or process related issues.
• Adhere to all requirements of the Quality Management System
• Other duties as required

Required qualifications:

• Bachelor’s degree in a relevant engineering discipline
• 4+ years of related work experience
• Experience working within a quality management system and quality system controls (e.g. design inputs/outputs, Verification/validation, etc.)
• Strong analytical and problem-solving abilities
• Strong oral and written communication skills, to communicate with individuals at various levels

Preferred qualifications:

• Bachelor’s degree in mechanical or biomedical engineering strongly preferred
• Experience working within medical device R&D departments, with hands-on prototyping and testing
• Experience using CAD software (e.g., SolidWorks)
• Knowledge of packaging materials including paperboard, corrugate, flexible packaging films, Tyvek, thermoformed trays, and manufacturing methods.
• Familiarity with industry related standards (e.g. ISO, ASTM, etc.) and their direct application

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:

• 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 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).

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
• 4+ years of related working experience from a regulated manufacturing industry
• 4+ 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:

• 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).