QXMedical LLC
Sr. Engineer
QXMedical LLC, Saint Paul, Minnesota, United States, 55199
Position Summary
Please note that the company is unable to provide sponsorship for employment visas, now or in the future.
The Senior Engineer will provide advanced development support for R&D projects and manufacturing processes, focusing primarily on mechanical engineering principles. This role requires extensive hands-on experience in laboratory and manufacturing environments, with a strong emphasis on mechanical design and optimization. The Senior Engineer will utilize design for manufacturing methods and tools to create robust, cost-effective solutions and drive innovation within the engineering team. Initiative, creativity, exceptional problem-solving abilities, and strong teamwork skills are essential for success in this role.
Primary Roles
As part of the Engineering Team, the Senior Engineer will perform duties as assigned by the Engineering leadership to achieve the team’s objectives and enhance overall project outcomes.
Major Accountabilities / Responsibilities
Serve as the Sr Engineer for major development projects or multiple concurrent projects, ensuring efficient coordination of engineering activities within established timelines.
Work closely with cross-functional teams to support R&D projects and manufacturing, including:
Leading product development activities such as mechanical design, prototyping/testing, and pilot production.
Conducting thorough risk assessments and design reviews, including Design Verification and Validation (DV&V) processes.
Establishing and validating mechanical manufacturing processes to ensure optimal functionality and compliance.
Evaluating product non-conformances and recommending necessary design modifications.
Enhance production capabilities through:
Analyzing and planning workflow, equipment layout, and spatial requirements to maximize manufacturing efficiency.
Reviewing and calculating labor, material, and production costs to support management in decision-making.
Ensuring compliance with all relevant government regulations and industry standards regarding manufacturing processes.
Overseeing equipment maintenance and repair services, ensuring adherence to manufacturers' specifications to keep production equipment operational.
Performing time studies to assess efficiency and identify opportunities for process improvement.
Proficient in technical writing/documentation.
Conducting hands-on mechanical experiments and tests, providing insights based on empirical data.
Mentoring/training junior Engineers.
Assembly and testing of catheter products, ensuring quality standards optimizing assembly processes for efficiency.
Education / Experience
Bachelor’s degree in Mechanical Engineering or a related field; advanced degree preferred.
Minimum of 5 years of hands-on experience in mechanical engineering, particularly in laboratory and manufacturing settings.
Proficiency in SolidWorks and AutoCAD is required; experience with other CAD software is a plus.
Demonstrated experience in rapid prototype design and development for proof of concept and usability testing.
Proven expertise in mechanical equipment design, building, and process improvement methodologies.
Highly developed mechanical aptitude with strong hands-on problem-solving skills in a lab environment.
Familiarity with Medical Device Directive (MDD), Medical Device Regulation (MDR), ISO 13485, FDA design controls, or similar regulatory frameworks is advantageous.
Key Skills
Strong analytical and technical skills
Excellent communication and interpersonal abilities
Ability to work collaboratively within cross-functional teams
Strong project management skills, with a focus on delivering results on time and within budget
Innovative mindset with a commitment to continuous improvement and quality assurance
Job Type:
Full-time
Pay:
$75,000.00 - $85,000.00 per year
Benefits:
401(k)
Dental insurance
Health insurance
Schedule:
8 hour shift
Experience:
Manufacturing: 5 years (Required)
Mechanical engineering: 5 years (Required)
Ability to Relocate:
Saint Paul, MN 55113: Relocate before starting work (Required)
Work Location:
In person
#J-18808-Ljbffr
Please note that the company is unable to provide sponsorship for employment visas, now or in the future.
The Senior Engineer will provide advanced development support for R&D projects and manufacturing processes, focusing primarily on mechanical engineering principles. This role requires extensive hands-on experience in laboratory and manufacturing environments, with a strong emphasis on mechanical design and optimization. The Senior Engineer will utilize design for manufacturing methods and tools to create robust, cost-effective solutions and drive innovation within the engineering team. Initiative, creativity, exceptional problem-solving abilities, and strong teamwork skills are essential for success in this role.
Primary Roles
As part of the Engineering Team, the Senior Engineer will perform duties as assigned by the Engineering leadership to achieve the team’s objectives and enhance overall project outcomes.
Major Accountabilities / Responsibilities
Serve as the Sr Engineer for major development projects or multiple concurrent projects, ensuring efficient coordination of engineering activities within established timelines.
Work closely with cross-functional teams to support R&D projects and manufacturing, including:
Leading product development activities such as mechanical design, prototyping/testing, and pilot production.
Conducting thorough risk assessments and design reviews, including Design Verification and Validation (DV&V) processes.
Establishing and validating mechanical manufacturing processes to ensure optimal functionality and compliance.
Evaluating product non-conformances and recommending necessary design modifications.
Enhance production capabilities through:
Analyzing and planning workflow, equipment layout, and spatial requirements to maximize manufacturing efficiency.
Reviewing and calculating labor, material, and production costs to support management in decision-making.
Ensuring compliance with all relevant government regulations and industry standards regarding manufacturing processes.
Overseeing equipment maintenance and repair services, ensuring adherence to manufacturers' specifications to keep production equipment operational.
Performing time studies to assess efficiency and identify opportunities for process improvement.
Proficient in technical writing/documentation.
Conducting hands-on mechanical experiments and tests, providing insights based on empirical data.
Mentoring/training junior Engineers.
Assembly and testing of catheter products, ensuring quality standards optimizing assembly processes for efficiency.
Education / Experience
Bachelor’s degree in Mechanical Engineering or a related field; advanced degree preferred.
Minimum of 5 years of hands-on experience in mechanical engineering, particularly in laboratory and manufacturing settings.
Proficiency in SolidWorks and AutoCAD is required; experience with other CAD software is a plus.
Demonstrated experience in rapid prototype design and development for proof of concept and usability testing.
Proven expertise in mechanical equipment design, building, and process improvement methodologies.
Highly developed mechanical aptitude with strong hands-on problem-solving skills in a lab environment.
Familiarity with Medical Device Directive (MDD), Medical Device Regulation (MDR), ISO 13485, FDA design controls, or similar regulatory frameworks is advantageous.
Key Skills
Strong analytical and technical skills
Excellent communication and interpersonal abilities
Ability to work collaboratively within cross-functional teams
Strong project management skills, with a focus on delivering results on time and within budget
Innovative mindset with a commitment to continuous improvement and quality assurance
Job Type:
Full-time
Pay:
$75,000.00 - $85,000.00 per year
Benefits:
401(k)
Dental insurance
Health insurance
Schedule:
8 hour shift
Experience:
Manufacturing: 5 years (Required)
Mechanical engineering: 5 years (Required)
Ability to Relocate:
Saint Paul, MN 55113: Relocate before starting work (Required)
Work Location:
In person
#J-18808-Ljbffr