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The manufacturing engineer for the assembly process is responsible for designing, scaling, and optimizing assembly operations for electromechanical medical device assemblies to ensure consistent, high-quality production. Designs assembly processes, tooling, and line layouts while establishing robust controls aligned with PFMEA and GMP requirements in a low volume / high mix environment. Serves as a technical liaison for customer design transfers, supports validation activities, and drives continuous improvement initiatives to enhance efficiency and reduce costs. Provides mentoring and training to production personnel, and acts as a subject matter expert in troubleshooting, CAPA, and GMP process compliance.
The manufacturing engineer for the assembly process is responsible for designing, scaling, and optimizing assembly operations for electromechanical medical device assemblies to ensure consistent, high-quality production. Designs assembly processes, tooling, and line layouts while establishing robust controls aligned with PFMEA and GMP requirements in a low volume / high mix environment. Serves as a technical liaison for customer design transfers, supports validation activities, and drives continuous improvement initiatives to enhance efficiency and reduce costs. Provides mentoring and training to production personnel, and acts as a subject matter expert in troubleshooting, CAPA, and GMP process compliance.
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Sturtevant, USA
Milwaukee, USA
Sturtevant, USA
Sturtevant, USA
Sturtevant, USA
Milwaukee, USA
Milwaukee, USA
Milwaukee, USA
Bachelor’s degree in mechanical, Biomedical, Manufacturing, Industrial Engineering, or a related technical field; or an associate’s degree in a technical discipline combined with relevant experience.
Minimum of 2 years of experience, or an equivalent combination of education and relevant manufacturing experience, in a production environment focused on mechanical and electrical assemblies. Includes hands-on experience in fixture and tooling design, manufacturing process development, and full product builds, as well as assembly line operations and electro-mechanical systems (medical device industry experience preferred).
Proficient in power tools, hand tools, precision measurement instruments, and electrical testing equipment.
Proficient in interpreting and creating engineering drawings, technical documentation, and specifications.
Proficient with SolidWorks, ProE, AutoCAD, or other CAD software.
Experience using root cause and problem-solving methodologies (DMAIC, 5 Whys, Fishbone, etc.).
Working knowledge of ISO 9001 & 13485 Quality System requirements.
Knowledge of FDA regulations is preferred.
Experience supporting continuous improvement initiatives.
Six Sigma Green Belt or Black Belt certification (preferred).
Proficiency in Microsoft Office Suite.
Frequent prolonged standing and sitting standing and walking in office, manufacturing, warehouse, or operational environments.
Occasional bending, reaching, climbing stairs, and light lifting (up to 40 lbs., if applicable).
Visual acuity to review data, analyze reports, and observe operational processes, with color perception required.
High level of analytical thinking and problem-solving to evaluate complex processes and identify root causes.
Ability to interpret data, metrics, and financial impact analyses to drive decisions.
Ability to manage multiple projects simultaneously with shifting priorities.
High attention to detail with strong organizational skills.
Effective communication skills, including presenting to customers and frontline teams.
Resilience and adaptability in dynamic operational settings.
Ability to receive and provide instructions in a positive manner.
Flexible to change and possess a high degree level of integrity and “can do attitude”.
Private medical-device CDMO designing and manufacturing complex electromechanical systems for medical-device OEMs.
Visit company websiteJobs and hiring trendsUSD 90000-105000 yearly / year
Full-time
Entry · 2+ years experience
Onsite
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