Manufacturing Engineer 13203

Manufacturing Engineer
Job Duties and Responsibilities
 • Work with NPD Engineers to develop manufacturing processes: especially sterile packaging systems for new products.
 • Perform equipment and process validations and testing to internal procedures and external standards.
• Develop and improve manufacturing and inspection processes and procedures.
 • Define equipment maintenance and calibration requirements for manufacturing equipment.
 • Lead or assist NPD team with process failure modes and effects analysis.
• Work with project managers to establish project timelines.
• Lead or assist NPD team to resolve issues with suppliers.
• Develop cleanliness and environmental control processes and procedures.
• Work with NPD team to create methods and machines that meet throughput standards.
• Participate in the training of manufacturing operators and quality control operators.
• Responsible for adherence to Cook’s Quality Policy Manual and Quality System Procedures.
Qualifications and Skills
 • Bachelor’s Degree in Mechanical, Electrical, Production, Manufacturing Engineering, or equivalent experience.
 • Must have at least two years’ experience in the medical device industry in a comparable role.
 • Must be capable of working on teams or alone, with effective written and verbal communications skills.
 • Must possess good organizational and prioritization skills to manage multiple competing assignments and priorities.
 • Prefer capability with CAD modelling in Solid Works
Role Summary
The NPI Manufacturing Engineer plans, directs, and develops manufacturing processes for new medical devices. The Manufacturing Engineer works with NPD (new products development) Engineering, Operations, Quality Assurance, and Regulatory Affairs. The NPI Manufacturing Engineer will introduce processes and equipment to support new product designs. The processes and equipment must be within defined quality metrics and operational costs, and in-compliance with regulatory standards. This position is on-site.
TriMech Services is an engineering resource provider specializing in the placement of qualified technical candidates for both temporary and direct hire opportunities.  TriMech Services offers a unique approach to matching the specialized skill sets of our candidates to our clients engineering specific requirements.