Senior Project Engineer - KLM Careers

Senior Project Engineer

Grand Rapids, MI

Must be a US Citizen or Green Card holder.

A growing contract manufacturer in the medical device industry is seeking a Senior Project Engineer to join its team. In this role you will lead and provide technical support for a variety of projects supporting both new product development and existing product modifications, working with both internal and external customers to create project quote, statement of work documents, procure new components and equipment, and gather input on new device designs.

This is a great opportunity to join a growing organization with a culture of teamwork and collaboration, and a focus on both high quality products and continuous improvement initiatives.

Senior Project Engineer Responsibilities

• Plan, strategize and execute projects for new product development and sustaining initiatives
• Follow all FDA regulations, ISO standards, customer requirements, and standard operating procedures (SOPs) as defined by company policies and procedures
• Work with customers to create quotes for new manufacturing and development business opportunities
• Conduct qualification and validation activities for process design and development, design of devices, and research of concepts.
• Identify new technology and innovations to improve design and manufacturing processes
• Work closely with the operations team to complete new product launches. This may include direct oversight of operations and personnel at times.
• Author and execute change orders, engineering project plans, and development plans.
• Communicate project status updates at regularly scheduled management team meetings and customer team meetings, and on-demand from customer requests.
• Design and build or facilitate purchase of manufacturing equipment, both automated and manual, for the purpose of assembly, packaging, quality assurance, testing or facility improvement.
• Provide mentorship and direction to other engineers and project team members.
• Identify opportunities for cost, lead time, inventory, and defect reduction.

Senior Project Engineer Qualifications

• Bachelors degree in engineering or a related field required; masters degree in engineering or MBA a plus.
• 5+ years of engineering related experience in the medical device industry, including manufacturing engineer and new product design experience.
• Experience with CAD, project management software, statistical analysis, and Microsoft Office Suite required.
• Experience with CNC mills and Swiss lathes preferred but not required.
• Detail-oriented, accurate, reliable, with strong organizational and time management abilities.
• Effective communication skills to collaborate with cross-functional teams and external customers.
• Ability to participate in and facilitate group meetings, including internal team meetings and external project supplier and customer meetings.
• Ability to work independently and meet deadlines in a fast-paced environment.
• Strong ethics and commitment to maintaining data confidentiality and integrity.
• Some travel may be required (less than 20%) to customer and/or supplier locations.

Required Knowledge, Skills, and Abilities: (Hiring Companies ATS Questions):

1. Do you have a Bachelors degree in engineering or a related field required; masters degree in engineering or MBA a plus.

2. Do you have 5+ years of engineering related experience in the medical device industry, including manufacturing engineer and new product design experience.

3. Do you have experience with CAD, project management software, statistical analysis, and Microsoft Office Suite required.

4. Do you have experience with CNC mills and Swiss lathes preferred but not required.

5. Are you ok with travel - may be required (less than 20%) to customer and/or supplier locations.

6. Must be a US Citizen or Green Card holder.