POSTED 06/03/2025
Manufacturing Engineer
Location: Roseville, MN
Manufacturing Engineer
Roseville, MN
Currently looking for skilled individuals to fill a direct hire Manufacturing Engineer opening with a company located in Roseville, MN. Interested candidates should have a bachelor's degree in mechanical engineering or a related field, a minimum of 5 years of industry related engineering experience, and experience working in the medical device manufacturing industry (ideally catheter manufacturing).
Manufacturing Engineer Job Description:
- Serve as the lead/project Engineer for major development projects or multiple simultaneous projects. Ensure that engineering activities are coordinated properly in a reasonable time frame.
- Work closely with cross-functional teams to support R&D projects and manufacturing such as:
- 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.
Manufacturing Engineer Job Requirement:
- Four-year degree in appropriate engineering discipline or related field.
- 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 Regulation (MDR), ISO 13485, FDA design controls, or similar regulatory framework.
- 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.
- Ability to lift up to 50 pounds.
Compensation for Manufacturing Engineer:
The starting salary for the Manufacturing Engineer position is $60,000 to $75,000 annually. Plus, benefits (health insurance, dental insurance, paid time off, 401(k), HAS, and profit-sharing opportunities (depending on company/employee performance))