Mechanical Engineering Manager R&D

JOB TITLE: Mechanical Engineering Manager R&D

JOB SUMMARY

The Mechanical Engineering Manager leads a skilled mechanical engineering team at our strategic Costa Rica R&D Center of Excellence, ensuring technical excellence across our advanced medical device portfolio. This role combines technical oversight with effective team management as you build your team from the ground up and guide both engineering performance and professional development. Reporting to the Head of R&D, Costa Rica, with a dotted line to the Senior Manager of Global Mechanical Engineering, you'll establish mechanical engineering as a key discipline in our newest R&D hub. Your experience will be valuable in building and strengthening team capabilities, delivering quality across sustaining programs, and identifying opportunities to enhance our life-saving technologies. We're seeking an engineering leader ready to shape a department from scratch, make an impact on our global organization, and deliver results that improve patient care worldwide.

ESSENTIAL DUTIES

• Establish and grow the mechanical engineering team from the ground up, while implementing best practices and fostering a culture of technical excellence.
• Spearhead mechanical engineering efforts across sustaining and continuous improvement projects that enhance our medical device portfolio.
• Drive functional excellence within the Mechanical Engineering Team, establishing best practices and fostering continuous improvement utilizing design controls.
• Mentor and develop mechanical engineers through technical guidance, career pathing, and performance management.
• Lead the recruitment and selection process to build a world-class mechanical engineering team with diverse technical capabilities.
• Partner with other engineering disciplines and cross-functional teams to ensure integrated approaches to technical challenges.
• Oversee multiple concurrent sustaining R&D initiatives, managing priorities, resources, and timelines.
• Maintain strict adherence to medical device industry regulations and quality standards across all engineering activities.
• Effectively manage project budgets and resources to maximize team efficiency and output.
• Develop and maintain relationships with key vendors and technology partners to enhance team capabilities.
• Present technical information and project status with clarity to senior management and stakeholders.
• Coordinate strategies, practices, and execution with the product design and development team in Colorado -USA, to ensure consistency across sites.
• Manage and provide leadership for the functional group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
• Responsible for the project and or work group expenditures vs. plan.
• Implement and understand FDA or regulatory requirements as necessary.
• Ensure compliance with Quality System regulations and safe working practices.
• Plan, guide, and review projects and or work groups under one’s control to produce the desired outcome.
• Utilize technical skills to evaluate proposed solutions, adaptations, and modifications to projects.

MINIMUM QUALIFICATION REQUIREMENTS

Education

Bachelor or Master of Science degree in Mechanical Engineering is required.

Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.

Experience

• Minimum of 7 years of experience in mechanical engineering, with a strong focus on medical device development.
• At least 3 years of experience in a supervisory or management capacity within the medical technology industry.
• Proven track record of successfully leading complex mechanical engineering projects for medical devices.
• Demonstrated experience with global regulatory requirements in the medical device industry.

Skills

• Proven leadership experience building and managing high-performing engineering teams in a multi-project environment.
• Advanced problem-solving and analytical skills specifically applied to medical device challenges.
• Comprehensive knowledge of mechanical engineering principles, practices, and standards essential to medical technology development.
• Expertise with mechanical design and PLM software used in medical device development, preferably with SolidWorks and Windchill.
• Demonstrated project management capabilities with a track record of successfully balancing competing priorities.
• Demonstrated project management capabilities with a track record of successfully balancing competing priorities.
• Identify potential risks and develop mitigation strategies to ensure project success and compliance with regulatory requirements
• Superior English communication skills for articulating complex technical concepts to diverse audiences, including senior management.
• Adaptability and resilience in fast-paced environments typical of innovative medical technology companies.
• Strategic decision-making abilities, particularly when navigating complex regulatory requirements and technical trade-offs.
• Thorough understanding of medical device industry regulations and standards (e.g., FDA, ISO 13485, IEC 60601).
• Experience managing engineering budgets and allocating resources effectively across multiple projects.
• Success working with geographically-dispersed engineering teams across multiple locations.

-Or- An equivalent competency level acquired through a variation of these qualifications may be considered.

Certificates, Licenses, Registrations:

• Must either have a current passport and US VISA or be eligible to obtain a passport and US Visa.

JOB TITLE: Mechanical Engineering Manager R&D

JOB SUMMARY

The Mechanical Engineering Manager leads a skilled mechanical engineering team at our strategic Costa Rica R&D Center of Excellence, ensuring technical excellence across our advanced medical device portfolio. This role combines technical oversight with effective team management as you build your team from the ground up and guide both engineering performance and professional development. Reporting to the Head of R&D, Costa Rica, with a dotted line to the Senior Manager of Global Mechanical Engineering, you'll establish mechanical engineering as a key discipline in our newest R&D hub. Your experience will be valuable in building and strengthening team capabilities, delivering quality across sustaining programs, and identifying opportunities to enhance our life-saving technologies. We're seeking an engineering leader ready to shape a department from scratch, make an impact on our global organization, and deliver results that improve patient care worldwide.

ESSENTIAL DUTIES

• Establish and grow the mechanical engineering team from the ground up, while implementing best practices and fostering a culture of technical excellence.
• Spearhead mechanical engineering efforts across sustaining and continuous improvement projects that enhance our medical device portfolio.
• Drive functional excellence within the Mechanical Engineering Team, establishing best practices and fostering continuous improvement utilizing design controls.
• Mentor and develop mechanical engineers through technical guidance, career pathing, and performance management.
• Lead the recruitment and selection process to build a world-class mechanical engineering team with diverse technical capabilities.
• Partner with other engineering disciplines and cross-functional teams to ensure integrated approaches to technical challenges.
• Oversee multiple concurrent sustaining R&D initiatives, managing priorities, resources, and timelines.
• Maintain strict adherence to medical device industry regulations and quality standards across all engineering activities.
• Effectively manage project budgets and resources to maximize team efficiency and output.
• Develop and maintain relationships with key vendors and technology partners to enhance team capabilities.
• Present technical information and project status with clarity to senior management and stakeholders.
• Coordinate strategies, practices, and execution with the product design and development team in Colorado -USA, to ensure consistency across sites.
• Manage and provide leadership for the functional group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
• Responsible for the project and or work group expenditures vs. plan.
• Implement and understand FDA or regulatory requirements as necessary.
• Ensure compliance with Quality System regulations and safe working practices.
• Plan, guide, and review projects and or work groups under one’s control to produce the desired outcome.
• Utilize technical skills to evaluate proposed solutions, adaptations, and modifications to projects.

MINIMUM QUALIFICATION REQUIREMENTS

Education

Bachelor or Master of Science degree in Mechanical Engineering is required.

Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.

Experience

• Minimum of 7 years of experience in mechanical engineering, with a strong focus on medical device development.
• At least 3 years of experience in a supervisory or management capacity within the medical technology industry.
• Proven track record of successfully leading complex mechanical engineering projects for medical devices.
• Demonstrated experience with global regulatory requirements in the medical device industry.

Skills

• Proven leadership experience building and managing high-performing engineering teams in a multi-project environment.
• Advanced problem-solving and analytical skills specifically applied to medical device challenges.
• Comprehensive knowledge of mechanical engineering principles, practices, and standards essential to medical technology development.
• Expertise with mechanical design and PLM software used in medical device development, preferably with SolidWorks and Windchill.
• Demonstrated project management capabilities with a track record of successfully balancing competing priorities.
• Demonstrated project management capabilities with a track record of successfully balancing competing priorities.
• Identify potential risks and develop mitigation strategies to ensure project success and compliance with regulatory requirements
• Superior English communication skills for articulating complex technical concepts to diverse audiences, including senior management.
• Adaptability and resilience in fast-paced environments typical of innovative medical technology companies.
• Strategic decision-making abilities, particularly when navigating complex regulatory requirements and technical trade-offs.
• Thorough understanding of medical device industry regulations and standards (e.g., FDA, ISO 13485, IEC 60601).
• Experience managing engineering budgets and allocating resources effectively across multiple projects.
• Success working with geographically-dispersed engineering teams across multiple locations.

-Or- An equivalent competency level acquired through a variation of these qualifications may be considered.

Certificates, Licenses, Registrations:

• Must either have a current passport and US VISA or be eligible to obtain a passport and US Visa.

JOB TITLE: Mechanical Engineering Manager R&D

JOB SUMMARY

The Mechanical Engineering Manager leads a skilled mechanical engineering team at our strategic Costa Rica R&D Center of Excellence, ensuring technical excellence across our advanced medical device portfolio. This role combines technical oversight with effective team management as you build your team from the ground up and guide both engineering performance and professional development. Reporting to the Head of R&D, Costa Rica, with a dotted line to the Senior Manager of Global Mechanical Engineering, you'll establish mechanical engineering as a key discipline in our newest R&D hub. Your experience will be valuable in building and strengthening team capabilities, delivering quality across sustaining programs, and identifying opportunities to enhance our life-saving technologies. We're seeking an engineering leader ready to shape a department from scratch, make an impact on our global organization, and deliver results that improve patient care worldwide.

ESSENTIAL DUTIES

• Establish and grow the mechanical engineering team from the ground up, while implementing best practices and fostering a culture of technical excellence.
• Spearhead mechanical engineering efforts across sustaining and continuous improvement projects that enhance our medical device portfolio.
• Drive functional excellence within the Mechanical Engineering Team, establishing best practices and fostering continuous improvement utilizing design controls.
• Mentor and develop mechanical engineers through technical guidance, career pathing, and performance management.
• Lead the recruitment and selection process to build a world-class mechanical engineering team with diverse technical capabilities.
• Partner with other engineering disciplines and cross-functional teams to ensure integrated approaches to technical challenges.
• Oversee multiple concurrent sustaining R&D initiatives, managing priorities, resources, and timelines.
• Maintain strict adherence to medical device industry regulations and quality standards across all engineering activities.
• Effectively manage project budgets and resources to maximize team efficiency and output.
• Develop and maintain relationships with key vendors and technology partners to enhance team capabilities.
• Present technical information and project status with clarity to senior management and stakeholders.
• Coordinate strategies, practices, and execution with the product design and development team in Colorado -USA, to ensure consistency across sites.
• Manage and provide leadership for the functional group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
• Responsible for the project and or work group expenditures vs. plan.
• Implement and understand FDA or regulatory requirements as necessary.
• Ensure compliance with Quality System regulations and safe working practices.
• Plan, guide, and review projects and or work groups under one’s control to produce the desired outcome.
• Utilize technical skills to evaluate proposed solutions, adaptations, and modifications to projects.

MINIMUM QUALIFICATION REQUIREMENTS

Education

Bachelor or Master of Science degree in Mechanical Engineering is required.

Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.

Experience

• Minimum of 7 years of experience in mechanical engineering, with a strong focus on medical device development.
• At least 3 years of experience in a supervisory or management capacity within the medical technology industry.
• Proven track record of successfully leading complex mechanical engineering projects for medical devices.
• Demonstrated experience with global regulatory requirements in the medical device industry.

Skills

• Proven leadership experience building and managing high-performing engineering teams in a multi-project environment.
• Advanced problem-solving and analytical skills specifically applied to medical device challenges.
• Comprehensive knowledge of mechanical engineering principles, practices, and standards essential to medical technology development.
• Expertise with mechanical design and PLM software used in medical device development, preferably with SolidWorks and Windchill.
• Demonstrated project management capabilities with a track record of successfully balancing competing priorities.
• Demonstrated project management capabilities with a track record of successfully balancing competing priorities.
• Identify potential risks and develop mitigation strategies to ensure project success and compliance with regulatory requirements
• Superior English communication skills for articulating complex technical concepts to diverse audiences, including senior management.
• Adaptability and resilience in fast-paced environments typical of innovative medical technology companies.
• Strategic decision-making abilities, particularly when navigating complex regulatory requirements and technical trade-offs.
• Thorough understanding of medical device industry regulations and standards (e.g., FDA, ISO 13485, IEC 60601).
• Experience managing engineering budgets and allocating resources effectively across multiple projects.
• Success working with geographically-dispersed engineering teams across multiple locations.

-Or- An equivalent competency level acquired through a variation of these qualifications may be considered.

Certificates, Licenses, Registrations:

• Must either have a current passport and US VISA or be eligible to obtain a passport and US Visa.