דרושים R&d Tech ב-Boston Scientific ב-United States, Marlborough

Your responsibilities will include:

• Test prototypes and components following standard test protocols.
• Organize, coordinate, and execute testing of packaging designs with engineering guidance.
• Support new test methods and/or revise existing test methods.
• Learn and apply standard test methods and processes.
• Prepare reports/documentation to communicate results to the technical community.
• Use developed networks in assisting engineering teams in obtaining necessary materials, services, and test data.
• Assist with problem solving.
• Assist in the set-up of experiments.
• Maintain testing database/tracking system.

Required qualifications:

• 0 – 1yrs with High School Diploma and/or background working in a technical, laboratory, or Quality role or equivalent combination of education/work experience.

Preferred qualifications:

• 0 – 2 years of experience in Packaging or related technical discipline.
• Good written, verbal and interpersonal communication skills.
• Work as a team player
• Good technical aptitude
• Strong attention to detail
• Familiarity with packaging materials
• Basic computer literacy (Excel, Outlook, etc)
• Knowledge related to packaging components (Film, Tyvek, Carton, Labels, Corrugated, Pouches).
• Experience performing visual inspections on Packaging materials preferred.
• Familiarity with ASTM / ISTA package testing requirements preferred.
• Familiarity with the medical device industry, FDA regulations, quality systems, and sterilization preferred.
• Ability to handle multiple tasks and effectively manage priorities.
• Ability to lift boxes up to 30lbs.

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

For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

About the role:

You will leverage deep technical expertise in C++ application development, the Linux operating system, and cybersecurity to architect, develop, and deliver robust, secure, and scalable systems. Your work will span the full software development lifecycle — from concept through commercialization — within a highly regulated environment.

Your responsibilities will include:

• Design, develop and release innovative high performance medical device software.
• Prototype and implement solutions in C++ ensuring high efficiency and maintainability.
• Provide technical knowledge to the team in software design and best in class software development methodologies and practices.
• Partner with other teams including marketing, systems engineering, QA, hardware and regulatory to understand requirements and bring the best solutions forward.
• Understands customer requirements and how they translate to application features.
• Implements, tests, troubleshoots, and debugs source code for software applications.
• Support testing strategies (Unit/Integration) and design verification protocols to verify software.
• Conducting code reviews and providing feedback to ensure adherence to best practices and coding standards.
• Follow the full design life cycle process including driving efforts in requirements specification, design activities, planning, code reviews and creating corresponding artifacts.
• Participating in the development of technical documentation, including design specifications, test plans, and user manuals.
• Promote a collaborative environment and pragmatic engineering decision-making.
• Identify and implement continuous improvements to work processes and tools.
• Support field clinical staff on use of medical software and troubleshooting of issues.
• Dedication to and enthusiasm for building products that save and improve lives.

Required qualifications:

• Bachelor’s degree or higher in Computer Science, Computer Engineering, Software Engineering, Electrical Engineering, or related major
• 5+ years of software development with fluency coding in multiple programming languages
• 1+ years of software development experience in medical device, aerospace, automotive, or defense products (medical device preferred).
• Strong oral and written communication skills
• Strong in solving complex problems and demonstrated ability to adapt, proactive and a positive influence on the rest of the team.
• Broad and deep technology experience including networking and cybersecurity.
• Expertise in Linux operating system deployment, customization, and security hardening.
• Proficiency in C++ (C++11 or newer), with experience developing coding standards and secure coding practices.

Preferred qualifications:

• Experience with software configuration management tools for source code control (Git), issue tracking (Jira), requirements management (Cockpit), code review tools (Code Collaborator) and 3rd party project build tools
• Experience in the medical device industry
• Experience with medical device regulatory standards including IEC 62304, 60601, FDA 510(k), ISO 14971, 13485
• Knowledge of cybersecurity best practices and standards

Base Salary Range

Minimum Salary: $ 86600

Maximum Salary: $ 164500

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

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Francisco Munoz Munoz

Your Responsibilities Include:

• Leads quality team in sustaining activities to support commercial product monitoring on projects of major magnitude and scope. Key Quality voice of influence on projects.
• Leads quality team on functional deliverables and ensures technical excellence for product or technical development.
• Owns and drives deliverables related to Design Controls, Risk Management, Product Performance, Quality, and Compliance, key partner in all department goals and objectives. Including leading V&V activities and failure investigations.
• Develops and implements quality strategies; seeks innovative approaches to attaining quality goals, including continuous improvement and VIP.
• Hire, develop, and coach direct and indirect reports to provide technical leadership and support of multiple projects, and drive best practices throughout the organization.
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Determines appropriate staff levels and schedules. Works with key partners to understand priorities and plans resource allocation accordingly.
• Maintains and enhances cross-functional team relationships.
• Provides significant guidance regarding technical strategies and approaches; works cross-functionally in identifying and resolving technical issues.
• Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements).
• Directly interfaces with internal and external audit activities.

What we're looking for:

• Minimum of a Bachelor's degree in Chemical, Biotechnology, Materials Science, Mechanical, Mechatronic or related field.
• Minimum of 6 years of related work experience or an equivalent combination of education and work experience
• Proven technical leadership and project management skills in medical device design, development, and commercialization
• Proven independent critical thinker, strong communication skills, strong presentation skills, and ability to build effective cross-functional relationships
• Ability to interface with customers to gather insight and get organizational buy-in on key design inputs
• Knowledge of Design Controls, Risk Management, NCEP/CAPA, Post-Market Surveillance, and FDA/ISO Medical Device Regulations
• Medical Device or regulated industry experience
• English level desired: 90%

About the Role:

The Endoscopy Research & Development (R&D) Design Center is seeking a motivatedto join our team. In this role, you will contribute mechanical engineering design support to new product development across multiple product lines. Working closely with subject matter experts, you will deliver design solutions, provide technical support, and ensure our products meet the highest standards of innovation and quality.

Your responsibilities will include:

• Mechanical Design : Design mechanisms, fixtures, and injection-molded components. Apply Geometric Dimensioning & Tolerancing (GD&T), perform tolerance analyses, and validate manufacturability.
• Drafting & Technical Print Review : Create and review technical drawings, ensuring adherence to drafting standards and accuracy. Conduct peer reviews for compliance and completeness.
• Finite Element Analysis (FEA) : Perform structural and mechanical analyses using ANSYS or similar FEA tools, providing design validation and optimization.
• Problem-Solving & Feasibility Studies : Analyze engineering problems, propose corrective or alternative solutions, and conduct feasibility studies to confirm product capabilities.
• Collaboration & Documentation : Work cross-functionally with design, manufacturing, and quality teams. Maintain thorough documentation throughout research and development phases.
• Communication : Present design results, analyses, and experimental findings to technical teams and management.

Required qualifications:

• Bachelor’s degree or higher in Mechanical Engineering or related discipline
• 2+ years of mechanical engineering experience (preferably in a regulated industry such as medical devices, aerospace, or automotive)
• 2+ years CAD expertise with proficiency in SolidWorks Design Software and SolidWorks ePDM (or equivalent)
• Demonstrated experience in drafting and technical print review with knowledge of GD&T standards
• Proven ability to design for injection molding, mechanisms, and fixtures
• Hands-on experience performing tolerance stack-up analyses and applying metrology principles
• 1 year FEA experience using ANSYS (or comparable software)
• Strong analytical and problem-solving skills with attention to detail

Preferred qualifications:

• Medical device industry experience, particularly in product development
• Certification in GD&T
• Practical knowledge of design for manufacturing (DFM) and diverse manufacturing processes
• Strong mechanical aptitude with a creative, unbiased approach to problem-solving

Maximum Salary: $ 138300

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

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

Costa Rica-Coyol

Hybrid Roles:

About the role:

Evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications. Assignments have clear and specified objectives and require the investigation of a limited number of variables. Improve existing manufacturing processes and act as liaison between production and engineering group in resolving problems encountered on the production floor. Assist with the introduction of new products into the Operations production area.

Your Responsibilities Include:

• Participates in project teams typically including one of the following: identifying and implementing process/product improvement alternatives to increase/optimize yield, efficiency, throughput, and/or performance; designing, performing, and documenting engineering test experiments to evaluate product/product performance; participating in Quality improvement activities; designing, developing, testing, and validating equipment, tools and fixtures; analyzing and interpreting process models and recommending process improvements; evaluates external process technologies; and other activities of limited scope requiring knowledge of principles and techniques commonly employed in the specific narrow area of assignments.
• Participate in equipment and process validation. Write protocols and reports for Equipment Installation Qualification, Operational Qualification and Process Performance Qualification.
• Participate in equipment and process validation. Write protocols and reports for Equipment Installation Qualification, Operational Qualification and Process Performance Qualification.
• Has working knowledge of Risk Management & Failure mode and effect analysis (FMEA) requirements.
• Interfaces with assemblers, production supervisors, and engineers in troubleshooting problems on the production floor.
• Coordinates with the appropriate suppliers and other external resources needed in developing and implementing process/product improvement plans.
• Acts independently to implement and follow through.
• Perform root cause analysis of failed product.
• Participates in project planning and scheduling.
• Optimize processes for yield improvements, cycle time improvements, and scrap reduction.
• Attends and contributes to product core team meetings.
• Performs responsibilities required by the Quality System and other duties as assigned or requested.

What we're looking for:

• Bachelor or Licenciature degree in Mechanical, Electromechanical, Electronic, Electrical Industrial Maintenance or related.
• Experience: At least 3 years
• English Level desired: 70-79%
• Technical Competencies: Problem Solving, Networking, Process Improvement, Lean manufacturing and Six Sigma knowledge, Process Validations.
• Knowledge of the Lab View programming
• Knowledge of automated vision systems

About this role:
The Principal Design Quality Assurance Engineer is a seasoned professional with experience in quality engineering and regulatory requirements for the medical device industry. This role serves as a driving force in the quality department, championing excellence, compliance, and continuous improvement across projects and teams. The position is part of the design site for the Endoscopy Division and supports activities such as New Product Development, Sustaining and Life Cycle Management, and Quality Systems initiatives related to design and development.

This is a hybrid position based out of Marlborough, MA with a minimum of three days per week onsite.

Your responsibilities include:

• Acts as the primary voice for quality within cross-functional teams, influencing project direction and ensuring adherence to regulatory requirements and best practices.
• Leads the execution of Quality Deliverables such as Project Design & Development Plan, Field Assessment Plan, Design Change, and Design & Usability Validation Plans. Leads the execution of the Risk Management deliverables to ensure compliance to ISO 14971 and demonstrates a primary commitment to patient safety. Guides the successful completion of major programs and may function in a project leadership role.
• Interfaces with senior management on significant matters, often requiring the coordination of activity across organizational units. May lead specialized technical project teams which have a broad impact on the company utilizing cross-functional resources. Acts as division representative on cross-divisional projects defining the quality system(s).
• Leverages deep technical knowledge to lead teams through complex problem-solving initiatives. Applies systematic approaches (e.g. 5 Whys, Is-Is Not, DMAIC and Six Sigma problem solving methodologies) to diagnose root causes, optimize processes, and ensure sustained corrective actions.
• Guides and mentors engineers, fostering a culture of learning, collaboration, and technical excellence. Provides coaching on quality engineering methodologies and problem-solving techniques.
• Establishes strong relationships across departments, effectively communicating quality priorities, presenting findings, and driving consensus among stakeholders. Uses influence and negotiation skills to integrate quality perspectives into business decisions.
• Identifies and implements best-in-class practices for the department. Proactively assesses opportunities for improvements or enhancement to quality systems and processes in the company.
• Supports internal and external regulatory audits as audit facing subject matter expert as required. Supports regulatory responses through technical writing and submission consultation as required.

What we’re looking for in you:
Required Qualifications

• Bachelor of Science in Biomedical Engineering, Mechanical Engineering or related degree.
• 8+ years of medical device engineering experience.
• In-depth knowledge of US and International medical device requirements including 21 CFR part 820, Medical Device Directive (MDD) / Medical Device Regulation (EU MDR), EN ISO 13485 and EN ISO 14971.
• Travel approximately 10-20%.

Preferred Qualifications

• 10+ years of medical device engineering experience.
• Expertise in Usability and Human Factors engineering.
• Proficiency in Minitab Statistical Analysis software or equivalent.
• Six Sigma Black Belt Certification.
• Strong technical expertise in quality engineering principles, design controls, risk management, and problem-solving methodologies.
• Excellent communication, presentation, and interpersonal skills, with the ability to influence teams and leadership.
• Proven ability to lead and coach others, driving a high-performance quality culture.
• Strategic mindset with hands-on execution, balancing long-term objectives with immediate project needs.
  

Maximum Salary: $ 197000

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

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

Your responsibilities will include:

• Compliance corporate safety procedures always and comply with access control regulations.
• Maintain, evaluate, repair and maintain all building maintenance items such as doors, chairs, furniture, perimeter roads, fencing, painting, lockset, wall, glass panel, speed bumps, signages, drainage, perimeter land, ceilings, flooring, roof, roller shutters, carpets, conference rooms & toilets.
• Work closely with facilities management any work that requires outside expert assistance.
• Supervise supplier who carried our job related to building maintenance.
• Familiarity with service level agreement and response to customer complaints on building maintenance issues.
• Performs scheduled and unscheduled building maintenance Preventative maintenance activity and close on time.
• Working on non-complicated project related to building maintenance improvement.
• Building, services and infrastructure inspection and documentation.
• Statutory compliance.
• Perform other duties in support of Facilities group.
  

Required qualifications:

• 2-4 Years with High School Diploma and/or equivalent experience, training , or apprenticeships

Maximum Salary: $ 93704

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

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.