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Manufacturing Engineering Manager
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AuST Manufacturing
West Valley City, UT (In Person)
$105,000 Salary, Full-Time
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Job Description
AuST Manufacturing is a rapidly-growing medical device design house and manufacturing facility, with an innovative and energetic team that is committed to providing high-quality products to our customers and patients. We are seeking a Manufacturing Engineering Manager. This role will be responsible for supporting and improving process control of our high volume manufacturing lines. This role plays a key part in supporting safety, quality, delivery, and cost as outputs of the high-volume manufacturing lines.
Key Responsibilities Manage, mentor, and develop a multidisciplinary process engineering team, cultivating technical depth, line ownership and leadership potential Set competency frameworks, performance objectives, and individual development plans to align line needs and business growth Ensure robust documentation of all processes, parameters, validations, controls Review deviations and non-conformances, serve as lead for product safety-level events Develop and track operational KPIs, including yield, NCR rate, safety, and OEE to strategically review and plan for resource allocation Establish and champion LEAN, Six Sigma, DMAIC, or similar methodologies, embedding a mindset and toolset for waste reduction Act as the critical liaison within the cross-functional team for engineering-related issues; partner with the CFT to drive customer-impacting results Serve as the point of contact for line-related issues, including requests for information to customers are required Review, approve, and provide guidance for engineering change orders Support customer deployment and technical troubleshooting for both internal and external customers Required Qualifications Bachelor's degree in Engineering (Mechanical Engineering preferred) 1-3 years of experience in a quality, manufacturing, or regulated industry role Experience initiating and managing NCRs in a regulated manufacturing environment (medical device preferred). Ability to improve, standardize, and train inspection methods for IQC and FQC. Strong data analysis and statistical skills. Working knowledge of SPC concepts (control charts, Cp/Cpk). Strong technical writing skills for protocols, reports, and documentation. Strong attention to detail and ability to work cross-functionally. Required Qualifications Bachelors degree in mechanical engineering, or other relevant engineering field 5-10 years engineering experience in regulated field Preferred qualifications Master's degree in mechanical engineering, or other relevant engineering field 5-10 years medical device manufacturing experience
Key Responsibilities Manage, mentor, and develop a multidisciplinary process engineering team, cultivating technical depth, line ownership and leadership potential Set competency frameworks, performance objectives, and individual development plans to align line needs and business growth Ensure robust documentation of all processes, parameters, validations, controls Review deviations and non-conformances, serve as lead for product safety-level events Develop and track operational KPIs, including yield, NCR rate, safety, and OEE to strategically review and plan for resource allocation Establish and champion LEAN, Six Sigma, DMAIC, or similar methodologies, embedding a mindset and toolset for waste reduction Act as the critical liaison within the cross-functional team for engineering-related issues; partner with the CFT to drive customer-impacting results Serve as the point of contact for line-related issues, including requests for information to customers are required Review, approve, and provide guidance for engineering change orders Support customer deployment and technical troubleshooting for both internal and external customers Required Qualifications Bachelor's degree in Engineering (Mechanical Engineering preferred) 1-3 years of experience in a quality, manufacturing, or regulated industry role Experience initiating and managing NCRs in a regulated manufacturing environment (medical device preferred). Ability to improve, standardize, and train inspection methods for IQC and FQC. Strong data analysis and statistical skills. Working knowledge of SPC concepts (control charts, Cp/Cpk). Strong technical writing skills for protocols, reports, and documentation. Strong attention to detail and ability to work cross-functionally. Required Qualifications Bachelors degree in mechanical engineering, or other relevant engineering field 5-10 years engineering experience in regulated field Preferred qualifications Master's degree in mechanical engineering, or other relevant engineering field 5-10 years medical device manufacturing experience