Ascendo
Design Supervisor
Ascendo, Jacksonville, Florida, United States, 32290
A Medical Device Design Supervisor is responsible for leading and overseeing the design and development of medical devices, ensuring that all products meet industry standards, regulatory requirements, and company objectives. This role requires a deep understanding of medical device engineering, project management, and team leadership. The supervisor plays a crucial role in guiding the design team, managing the design process, and ensuring the successful delivery of innovative and safe medical devices.
Key Responsibilities:
Leadership and Supervision: Lead, mentor, and supervise a team of design engineers and technicians, providing guidance and support to ensure high-quality design outcomes.Project Management: Oversee the planning, scheduling, and execution of design projects, ensuring that all milestones are met within budget and on time.Design and Development: Collaborate with cross-functional teams to develop innovative medical device designs, from concept through to production, ensuring compliance with industry standards and regulations.Quality Assurance: Implement and maintain quality control procedures throughout the design process to ensure that all products meet the necessary safety and performance standards.Regulatory Compliance: Ensure that all designs comply with relevant regulatory requirements, including FDA, ISO, and other international standards.Documentation and Reporting: Maintain accurate and comprehensive design documentation, including design plans, specifications, testing protocols, and validation reports.Continuous Improvement: Identify opportunities for process improvements in the design and development workflow, and implement changes to enhance efficiency and product quality.Technical Expertise: Provide technical expertise and problem-solving support to the design team, addressing complex design challenges and ensuring optimal solutions.Stakeholder Communication: Communicate effectively with internal and external stakeholders, including senior management, manufacturing teams, suppliers, and regulatory bodies.Training and Development: Develop and deliver training programs for team members to enhance their skills and ensure they are up-to-date with the latest industry trends and technologies.Qualifications:
Education: Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a related field. A Master's degree is preferred.Experience: 5+ years of experience in medical device design, with at least 2 years in a supervisory or leadership role.Technical Skills: Proficiency in CAD software (such as SolidWorks, AutoCAD), understanding of design for manufacturing (DFM), design controls, and risk management processes.Regulatory Knowledge: Strong knowledge of FDA regulations, ISO 13485, and other relevant standards for medical devices.Project Management: Experience in managing complex design projects, with strong organizational and time-management skills.Communication: Excellent written and verbal communication skills, with the ability to present complex technical information clearly to both technical and non-technical audiences.Problem-Solving: Strong analytical and problem-solving abilities, with a focus on innovative and practical solutions.Team Leadership: Proven ability to lead and motivate a team, fostering a collaborative and productive work environment.Preferred Qualifications:
Advanced Certifications: Certifications in Project Management (PMP) or Six Sigma are advantageous.Experience with Regulatory Submissions: Prior experience in preparing and submitting design dossiers for regulatory approval.Knowledge of Emerging Technologies: Familiarity with emerging trends in medical device design, such as additive manufacturing and digital health technologies.
This role is crucial for ensuring that medical devices are designed to the highest standards, meeting the needs of patients and healthcare providers while adhering to regulatory requirements. The Medical Device Design Supervisor must balance technical expertise with strong leadership and project management skills to drive successful product development.Ascendo is a certified minority owned staffing firm, and we welcome and celebrate diversity. Ascendo is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, parental status, military service or any other characteristic protected by federal, state or local law.
Ascendo is a certified minority owned staffing firm, and we welcome and celebrate diversity. Ascendo is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, parental status, military service or any other characteristic protected by federal, state or local law.
Contact information
Bradley Wallace
Key Responsibilities:
Leadership and Supervision: Lead, mentor, and supervise a team of design engineers and technicians, providing guidance and support to ensure high-quality design outcomes.Project Management: Oversee the planning, scheduling, and execution of design projects, ensuring that all milestones are met within budget and on time.Design and Development: Collaborate with cross-functional teams to develop innovative medical device designs, from concept through to production, ensuring compliance with industry standards and regulations.Quality Assurance: Implement and maintain quality control procedures throughout the design process to ensure that all products meet the necessary safety and performance standards.Regulatory Compliance: Ensure that all designs comply with relevant regulatory requirements, including FDA, ISO, and other international standards.Documentation and Reporting: Maintain accurate and comprehensive design documentation, including design plans, specifications, testing protocols, and validation reports.Continuous Improvement: Identify opportunities for process improvements in the design and development workflow, and implement changes to enhance efficiency and product quality.Technical Expertise: Provide technical expertise and problem-solving support to the design team, addressing complex design challenges and ensuring optimal solutions.Stakeholder Communication: Communicate effectively with internal and external stakeholders, including senior management, manufacturing teams, suppliers, and regulatory bodies.Training and Development: Develop and deliver training programs for team members to enhance their skills and ensure they are up-to-date with the latest industry trends and technologies.Qualifications:
Education: Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a related field. A Master's degree is preferred.Experience: 5+ years of experience in medical device design, with at least 2 years in a supervisory or leadership role.Technical Skills: Proficiency in CAD software (such as SolidWorks, AutoCAD), understanding of design for manufacturing (DFM), design controls, and risk management processes.Regulatory Knowledge: Strong knowledge of FDA regulations, ISO 13485, and other relevant standards for medical devices.Project Management: Experience in managing complex design projects, with strong organizational and time-management skills.Communication: Excellent written and verbal communication skills, with the ability to present complex technical information clearly to both technical and non-technical audiences.Problem-Solving: Strong analytical and problem-solving abilities, with a focus on innovative and practical solutions.Team Leadership: Proven ability to lead and motivate a team, fostering a collaborative and productive work environment.Preferred Qualifications:
Advanced Certifications: Certifications in Project Management (PMP) or Six Sigma are advantageous.Experience with Regulatory Submissions: Prior experience in preparing and submitting design dossiers for regulatory approval.Knowledge of Emerging Technologies: Familiarity with emerging trends in medical device design, such as additive manufacturing and digital health technologies.
This role is crucial for ensuring that medical devices are designed to the highest standards, meeting the needs of patients and healthcare providers while adhering to regulatory requirements. The Medical Device Design Supervisor must balance technical expertise with strong leadership and project management skills to drive successful product development.Ascendo is a certified minority owned staffing firm, and we welcome and celebrate diversity. Ascendo is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, parental status, military service or any other characteristic protected by federal, state or local law.
Ascendo is a certified minority owned staffing firm, and we welcome and celebrate diversity. Ascendo is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, parental status, military service or any other characteristic protected by federal, state or local law.
Contact information
Bradley Wallace