Senior Project Engineer
KLM Careers
- Grand Rapids, MI
- Permanent
- Full-time
- 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.
- 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.