Medical Device Engineer

Vintti stands at the forefront of economically advantageous staffing solutions for US businesses. By facilitating partnerships between American companies and Latin American professionals, we offer a pathway to reduced operational costs without sacrificing quality. Our approach enables businesses to reinvest savings into core areas, fostering growth and enhancing overall market competitiveness.

A Medical Device Engineer is responsible for designing, developing, and testing medical devices that improve patient care and well-being. They work closely with healthcare professionals to understand clinical needs and regulatory requirements, ensuring that the devices meet safety and performance standards. Utilizing a blend of engineering principles, materials science, and biocompatibility knowledge, Medical Device Engineers contribute to innovations in diagnostics, treatment, and rehabilitation. Their role encompasses prototyping, iterative testing, and eventual product launch while focusing on compliance with stringent health regulations and industry benchmarks.

- Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or related field
- Minimum of 3-5 years of experience in medical device design and development
- Proficiency in CAD software (e.g., SolidWorks, AutoCAD)
- Thorough understanding of medical device regulatory standards (e.g., FDA, ISO 13485)
- Experience with risk management (e.g., ISO 14971)
- Strong knowledge of materials science and biocompatibility
- Demonstrated experience in prototype development and testing
- Excellent problem-solving and troubleshooting skills
- Ability to work collaboratively in cross-functional teams
- Strong written and verbal communication skills
- Experience with project management and timeline/budget management
- Familiarity with quality management systems and documentation practices
- Knowledge of validation/verification processes and protocols
- Ability to work in a fast-paced, deadline-driven environment
- Strong attention to detail and organizational skills
- Willingness to stay updated with industry trends and advancements
- Experience in mentoring and training junior engineers
- Up-to-date knowledge of health and safety regulations in engineering

- Design and develop new medical devices from concept to final product
- Conduct research and testing to ensure product safety and efficacy
- Collaborate with cross-functional teams including R&D, clinical, regulatory, and manufacturing
- Prepare detailed engineering documentation, including schematics, specifications, and test reports
- Perform risk analysis and develop mitigation strategies for potential device failures
- Stay updated with regulatory standards and ensure compliance in all design and development processes
- Conduct feasibility studies and prototype testing to refine device functionality
- Troubleshoot and resolve design and production issues as they arise
- Provide technical support during clinical trials and product launch phases
- Perform continuous improvement activities to enhance existing medical devices
- Coordinate with suppliers and manufacturers to source necessary components and materials
- Develop and maintain project timelines and budgets
- Participate in regular team meetings to discuss project progress and alignment
- Train and mentor junior engineers and new hires on engineering best practices and processes
- Participate in user feedback sessions to gather input for device improvements
- Document all phases of engineering development in accordance with quality management systems
- Ensure all engineering activities adhere to health and safety regulations
- Review and approve validation plans and protocols for device testing

The ideal candidate for the Medical Device Engineer position will possess a Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related field, along with 3-5 years of hands-on experience in medical device design and development. They will demonstrate proficiency in CAD software such as SolidWorks or AutoCAD and have an in-depth understanding of regulatory standards like FDA and ISO 13485, as well as experience with risk management per ISO 14971. The candidate will showcase strong knowledge in materials science and biocompatibility, exceptional problem-solving and troubleshooting skills, and a proven track record in prototype development and testing. They will excel at working collaboratively with cross-functional teams and communicate effectively, both written and verbally, while also demonstrating robust project management skills including timeline and budget maintenance. This candidate will have a meticulous eye for detail and thrive in a fast-paced, deadline-driven environment. They will be self-motivated, proactive, and adaptable to changing priorities, showing resilience under pressure. Known for their creativity, innovative thinking, and high ethical standards, they will maintain accountability and ownership of all tasks and responsibilities. Additionally, they will be enthusiastic about mentoring junior engineers and continuously improving their knowledge of industry trends. Their strong organizational and time management skills, coupled with a strategic mindset and empathetic understanding of user needs, will allow them to drive projects to excellence.

- Design and develop new medical devices from concept to final product
- Conduct research and testing to ensure product safety and efficacy
- Collaborate with cross-functional teams including R&D, clinical, regulatory, and manufacturing
- Prepare detailed engineering documentation, including schematics, specifications, and test reports
- Perform risk analysis and develop mitigation strategies for potential device failures
- Stay updated with regulatory standards and ensure compliance in all design and development processes
- Conduct feasibility studies and prototype testing to refine device functionality
- Troubleshoot and resolve design and production issues as they arise
- Provide technical support during clinical trials and product launch phases
- Perform continuous improvement activities to enhance existing medical devices
- Coordinate with suppliers and manufacturers to source necessary components and materials
- Develop and maintain project timelines and budgets
- Participate in regular team meetings to discuss project progress and alignment
- Train and mentor junior engineers and new hires on engineering best practices and processes
- Participate in user feedback sessions to gather input for device improvements
- Document all phases of engineering development in accordance with quality management systems
- Ensure all engineering activities adhere to health and safety regulations
- Review and approve validation plans and protocols for device testing

- Strong creativity and innovative thinking
- High level of analytical and critical thinking
- Detail-oriented with meticulous attention to detail
- Exceptional communication skills
- Team-player with strong collaboration skills
- Ability to adapt quickly to changing priorities and environments
- Self-motivated and proactive in driving projects forward
- Patient and resilient under pressure
- Strong ethical standards and integrity
- Accountability and ownership of tasks and responsibilities
- Curiosity and eagerness to learn new technologies
- Empathy and understanding of user needs
- Results-driven with a focus on quality and excellence
- Strategic mindset with effective problem-solving abilities
- Ability to manage and balance multiple projects concurrently
- Enthusiastic about continuous improvement and innovation
- Leadership qualities and willingness to mentor others
- Open to receiving and providing constructive feedback
- Strong organizational and time management skills

- Competitive salary range commensurate with experience
- Comprehensive health, dental, and vision insurance
- Retirement savings plan with company match
- Paid time off (PTO) and holidays
- Flexible work hours and remote work options
- Professional development and training opportunities
- Tuition reimbursement for advanced degrees and certifications
- Wellness programs and gym membership discounts
- Employee assistance programs for mental health and well-being
- Performance-based bonuses and incentives
- Relocation assistance if applicable
- Life insurance and disability coverage
- Opportunities for advancement and career growth
- Company-sponsored social and networking events
- Collaborative and inclusive work culture
- Access to state-of-the-art facilities and equipment
- Technical and leadership training workshops
- Mentorship programs and peer support groups
- Free or discounted company products and services
- Work-life balance initiatives, including parental leave and family support programs