Sr. Manufacturing Engineer
What We NeedPicocyl is growing at an unprecedented rate in both production volume and scope of operations, and we are looking for a Senior Manufacturing Engineer to enable this growth. The successful candidate in this position will:
o Manage manufacturing engineering projects:
Handle all aspects of projects to onboard new product lines and new manufacturing equipment, and to optimize existing production processes. Manage relationships with automation vendors, plan projects, maintain project schedules, and report technical and financial progress to leadership. o Develop and implement new automation solutions:
Own all technical aspects of large automation projects. Analyze customer and product requirements, design new components as required, and generate applicable assembly processes and automation URS documents. Collaborate with automation equipment vendors to design and build solutions. Conduct equipment acceptance tests and ensure equipment conformance to specified requirements. Write and release production work instructions for the new equipment and related ancillary processes. o Validate automation solutions:
Using your medical device and automation expertise, develop efficient and robust validation approaches to new automated processes. Write protocols, execute them, and write validation reports. Efficiently manage the review and release of these documents within the Picocyl document control system. o Mentor other engineers:
Use your experience to advance your colleagues' knowledge of manufacturing engineering principles. Field questions and coach others thru problem analysis and solutions. Share your knowledge and lead others to execute aspects of your projects. o Keep the production floor running:
Attend to production issues with a sense of urgency. Troubleshoot issues and implement solutions. Document your work thoroughly in the Picocyl quality system thru appropriate use of NCRs, Deviations, Engineering Analysis Reports, and Change Orders.What You Need o BS in a related engineering field (e.g. mechanical, chemical, biomedical, or manufacturing engineering, or materials science and engineering) o 7
years of related engineering experience in a fast-paced, demanding manufacturing environment o Experience in the medical device industry working in an ISO 13485-compliant quality management system o Experience successfully managing large projects o Ability and willingness to mentor and guide other engineers o Strong technical writing skills o Design experience (e.g. assembly and inspection fixtures, tooling, product components) o Experience in automated assembly equipment and operations o Experience in time and cost analysis of manufacturing processes o Knowledge of lean/6 sigma concepts and methodology o Competence in basic manufacturing engineering skills, such as:
- Structured problem solving- Root cause analysis- Formulating effective corrective actions- Design work- Real-time production supportSalary range:
$115,000 - $130,000 Recommended Skills Assembly And Installation Biomedical Engineering Coaching And Mentoring Corrective And Preventive Action (Capa) Cost Benefit Analysis Document Management Systems Apply to this job. Think you're the perfect candidate? Apply on company site $(document).ready( function() $(#ads-desktop-placeholder).html(
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n Estimated Salary: $20 to $28 per hour based on qualifications.
o Manage manufacturing engineering projects:
Handle all aspects of projects to onboard new product lines and new manufacturing equipment, and to optimize existing production processes. Manage relationships with automation vendors, plan projects, maintain project schedules, and report technical and financial progress to leadership. o Develop and implement new automation solutions:
Own all technical aspects of large automation projects. Analyze customer and product requirements, design new components as required, and generate applicable assembly processes and automation URS documents. Collaborate with automation equipment vendors to design and build solutions. Conduct equipment acceptance tests and ensure equipment conformance to specified requirements. Write and release production work instructions for the new equipment and related ancillary processes. o Validate automation solutions:
Using your medical device and automation expertise, develop efficient and robust validation approaches to new automated processes. Write protocols, execute them, and write validation reports. Efficiently manage the review and release of these documents within the Picocyl document control system. o Mentor other engineers:
Use your experience to advance your colleagues' knowledge of manufacturing engineering principles. Field questions and coach others thru problem analysis and solutions. Share your knowledge and lead others to execute aspects of your projects. o Keep the production floor running:
Attend to production issues with a sense of urgency. Troubleshoot issues and implement solutions. Document your work thoroughly in the Picocyl quality system thru appropriate use of NCRs, Deviations, Engineering Analysis Reports, and Change Orders.What You Need o BS in a related engineering field (e.g. mechanical, chemical, biomedical, or manufacturing engineering, or materials science and engineering) o 7
years of related engineering experience in a fast-paced, demanding manufacturing environment o Experience in the medical device industry working in an ISO 13485-compliant quality management system o Experience successfully managing large projects o Ability and willingness to mentor and guide other engineers o Strong technical writing skills o Design experience (e.g. assembly and inspection fixtures, tooling, product components) o Experience in automated assembly equipment and operations o Experience in time and cost analysis of manufacturing processes o Knowledge of lean/6 sigma concepts and methodology o Competence in basic manufacturing engineering skills, such as:
- Structured problem solving- Root cause analysis- Formulating effective corrective actions- Design work- Real-time production supportSalary range:
$115,000 - $130,000 Recommended Skills Assembly And Installation Biomedical Engineering Coaching And Mentoring Corrective And Preventive Action (Capa) Cost Benefit Analysis Document Management Systems Apply to this job. Think you're the perfect candidate? Apply on company site $(document).ready( function() $(#ads-desktop-placeholder).html(
n
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n Estimated Salary: $20 to $28 per hour based on qualifications.
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