Full-time

5,001-10,000 employees · IT Services and IT Consulting

About the job

• Actalent is currently seeking a **Senior** Manufacturing/Process Engineer to join a great team working on custom medical devices in the Salt Lake City area!*
• Description:* They are looking for a Manufacturing Process Engineer who will be responsible for supporting and improving the manufacturing of class II medical and surgical devices in a dynamic, customer-focused organization. This person will be expected to work with customers to understand the product and process specifications, develop manufacturing processes, and build and test devices to those specifications. They will also be expected to document all of these activities according to design control requirements. This person will also function as an individual contributor in a small cross-functional team comprised of engineering, operations, and quality members to provide process and manufacturability input to designs throughout the product development process. They will support verification, validation, and regulatory submissions of these devices, then lead the transfer of the products to production and ensure a smooth transition to the production engineering team.
• MUST HAVES:*
• Bachelor's degree in Engineering or related field (Mechanical, Biomedical, Chemical) (Required).
• The ability to influence a team toward business objectives (Required).
• Must be able to function with little or no supervision (Required).
• Proficient with medical process validation, including (IQ, OQ, PQ), test method definition, root cause analysis, test method validations, measurement systems analysis (MSA), root cause analysis, and structured problem solving (Required).
• NICE TO HAVE:*
• A minimum of 4 years of related work experience in the medical device (open to other regulated industry backgrounds such as Aerospace and Automotive)
• Experience working through all aspects of medical device design & development including design verification and validation, process validation, and technology transfer (Preferred).
• The ability to perform statistical analysis using k-factors, Ppk, and DOEs along with root cause analysis (Preferred).
• Proficiency in solid 3-D modeling (i.e. SolidWorks) (Preferred).
• Design for manufacturability and assembly (DFMA) (Preferred).
• Skills:* Medical device, New product development, Design, Development, Process development, Feasibility study, iso 13485, Mechanical, Electrical, Engineering, Mechanical engineering, Validation, Research & development
• Additional Skills & Qualifications:* EXTERNAL DUTIES:
• Develop and improve manufacturing processes for new and existing products
• Support and troubleshoot equipment, programs, and processes already in production
• Design machines, tooling, and fixtures for new and existing products
• Author and execute process validation activities.
• Develop the manufacturing processes and flow to meet product cost targets.
• Provide manufacturability input to product development engineers during the product development process.
• Respond to customer complaints and initiate action to prevent reoccurrence of non-conformities related to the product, service, processes, or the quality system
• Demonstrating knowledge of project management principles.
• Implement continuous improvement actions in conjunction with the Production Engineering team to ramp up production of new products to meet customer demand curves and cost targets.
• Experience Level:* Expert Level
  
  

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.