Manufacturing Project Engineer

This is an exciting opportunity to participate in KDI’s rapid growth cycle and contribute to the extraordinary customer experience through development and improvement of manufacturing processes for a variety of medical devices. Working in the dynamic medical device contract manufacturing environment, the Manufacturing Project Engineer will have a strong grasp of manufacturing methodologies and be responsible for integrating new products into the manufacturing processes, ensuring they are delivered on time, within budget, and meeting quality standards. The Project Engineer is responsible for timely project execution and completion of key milestones for electro-mechanical medical system assembly and machine shop operations. The individual in this role will be a critical team member with highly visible tasks and opportunities for development and growth within KDI’s organization.

Responsibilities:

• Act as a project manager defining and communicating build schedules, milestones, and project status to key customers and stakeholders.
• Develop strong working relationships with customer technical counterparts to serve as their primary liaison to deliver product technical information, manage product specifications, communicate product change information, conduct installation issue resolutions, and facilitate customer requests.
• Coordinate and communicate closely with the customer(s) on projects as they are transitioned into KDI manufacturing.
• Plan, organize, and conduct complex technical projects and/or serve as the technical expert overseeing the development of engineering projects.
• Manage design reviews and project scheduled for each project.
• Perform professional engineering assignments of varying and significant complexity under general direction with considerable discretion as to work detail, and provide guidance and direction to other engineering staff in completing complex assignments.
• Collaborates with project managers and customers to establish a reasonable project development schedule from concept to production implementation that is in line with overall business requirements.
• Develop and optimize internal manufacturing processes for new products, by selecting the appropriate resources, equipment, and tooling
• Design products, parts, assembly and test fixtures using SolidWorks CAD software to create models and assembly & component detailed drawings.
• Write detailed Work Instructions for the assembly, inspection and packaging of products per customer and KDI internal requirements.
• Provide training, support and technical assistance to the medical assembly and machining departments on new processes and procedures. Work closely with production staff on daily tasks.
• Coordinate with KDI Buyer/ Planner and suppliers to assure that materials are ordered and received at the appropriate revision levels and in sync with the project schedule.
• Ensure compliance with quality standards and regulatory requirements.
• Plan and perform process validations.
• Prepare Risk Management Plans and PFMEA’s.
• Prepare and implement Engineering Change Orders (ECO’s).
• Lead Lean and Process Improvement activities.

Qualifications:

Required Qualifications

• Bachelor’s degree in engineering or science field is required.
• 3 years of experience in a manufacturing process development role in a manufacturing and/or medical device environment.

Preferred Qualifications and Competencies

• Strong project management skills with the ability to manage multiple projects simultaneously in a fast-paced environment.
• Effective and timely decision-making skills to keep projects and the organization moving forward.
• Expertise managing customer and vendor relationships.
• Excellent communication and interpersonal skills.
• Demonstrated ability to learn and execute engineering projects.
• Strong business acumen and drive to succeed.
• Problem-solving mindset with a focus on continuous improvement.
• Capable of working and effectively communicating with employees at multiple levels within the organization including senior management, engineering, production, and machine operators/ assemblers.
• The ability to manage multiple activities simultaneously with minimal direction while shifting priorities as they change is critical to this position.
• Strong attention to detail, analytical and problem-solving skills
• Proven competence in 3D CAD required (SolidWorks preferred).
• Must be proficient with MS Office products (Word, Excel, Outlook, PowerPoint, etc.).
• Understanding of cGMP and/or ISO 13485 is a plus.
• Experience with machining and / or assembly of Class I and Class II medical products
• Able to adapt to changing duties and responsibilities
• ‘Can-do-it’ attitude is a must

Seeking local candidates. Immediate hiring need.

Base Salary Range: $90,000.00 - $120,000.00 per year

Benefits:

• Market competitive salary
• 401K and profit-sharing plan
• Health, HSA, Dental, Life, Long and Short-Term Disability Insurance

Job Type: Full-time

Work Location: In person (Rogers, MN).