SMC Ltd
About SMC Ltd:
SMC, Ltd. is a globally recognized premium supplier to the medical market with locations throughout the world. People committed to speed, technology, and exceptional performance are the cornerstone of our organization. Comprised of dedicated people and decades of manufacturing experience, we have continued to experience strong growth and currently have outstanding career opportunities for equally dedicated people.
Job Summary
Manage the development of new programs from quotation support, through development and validation of molds, equipment, manufacturing processes, and successful transfer to Manufacturing. Essential Job Duties and Responsibilities
Lead programs and SMC program team that supports the development efforts of a new program. Work within the pharmaceutical or medical device industry with an understanding of industry standards, regulations, and compliance expectations. Collaborate with internal and external resources to research, design, and develop molds, tooling, processes, automation, fixtures, EOAT, secondary equipment, and other elements of the program. Maintain effective communication within the team and with stakeholders; act as the primary interface for the customer. Develop program timelines that align with quoted lead-times and customer validation, pilot builds, and approvals. Manage the program to meet customer deliverables and ensure a robust development and manufacturing process within quality and financial targets. Apply program management practices with cross-functional teams, including action item tracking, meeting minutes, scope changes, risk tracking, prioritization, problem solving, escalation, and cross-functional support. Provide technical interface with the customer and gather product requirements. Review product designs for compliance with engineering principles, standards, and customer specifications. Provide technical input in product design, material selection, mold design, manufacturing, secondary operations, statistics, process validations, Quality Management System, and related industry areas. Ensure thorough development through mold, process, or assembly testing to support a robust manufacturing process. Drive DOE objectives, resolve testing issues, and review validation reports and project summaries. Develop and gather documentation during project setup and development phases. Provide status updates to management on a regular basis. Manage Device Master Record (DMR) and PPAP to ensure internal documentation is up to date at Release to Manufacturing (RTM). Provide post-RTM internal support and resolve any new issues that arise. Control project scope and monitor customer PO coverage. Track team time and align with customer coverage. Support sales by providing technical expertise and identifying new opportunities with existing customers; support quoting as requested. Maintain a safe work environment by following all company safety policies and procedures. May mentor junior engineers and support their career development; may advocate for the team and align goals with site objectives; conduct regular one-on-one meetings to ensure alignment on program and personal goals. Regular on-site attendance and professionalism are required. Perform other duties as assigned. Essential Qualifications
Bachelor of Science in Engineering, preferably Plastics. Minimum seven (7) years’ experience, preferably in contact manufacturing within the Plastics Injection Molding Industry. Ability to multi-task, stay organized, and manage time effectively. Excellent written and verbal communication skills for sensitive and confidential situations. Strong technical and proposal writing skills; solid presentation and computer proficiency. Ability to exercise sound judgment in problem solving. Working knowledge of 3D CAD software, Microsoft Office Suite, and ERP systems (Solidworks and IQMS preferred). PMI Certification is desirable. English proficiency in reading, writing, and communication. ADA Requirements
Stand, walk, bend, squat, twist, reach or move frequently. Occasional repetitive motion and grasping; occasional climbing to reach areas on machines or racks. Lift, move, or transfer up to 50 lbs occasionally; >20 lbs frequently. Typically sits and uses a computer; exposure to typical machine shop hazards which may require respiratory protection. Ability to travel up to 25% of the time as needed. What SMC has to offer
Clean, climate-controlled environment Stable schedule Paid holidays and PTO Health, dental, and vision insurance 401(k) retirement savings Life and disability insurance Promotional opportunities Training and career growth programs Amazing co-workers Tuition reimbursement Employee Assistance Program SMC Ltd. is an equal opportunity employer. M/F/D/V; this organization uses E-Verify. Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments. #IND
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Manage the development of new programs from quotation support, through development and validation of molds, equipment, manufacturing processes, and successful transfer to Manufacturing. Essential Job Duties and Responsibilities
Lead programs and SMC program team that supports the development efforts of a new program. Work within the pharmaceutical or medical device industry with an understanding of industry standards, regulations, and compliance expectations. Collaborate with internal and external resources to research, design, and develop molds, tooling, processes, automation, fixtures, EOAT, secondary equipment, and other elements of the program. Maintain effective communication within the team and with stakeholders; act as the primary interface for the customer. Develop program timelines that align with quoted lead-times and customer validation, pilot builds, and approvals. Manage the program to meet customer deliverables and ensure a robust development and manufacturing process within quality and financial targets. Apply program management practices with cross-functional teams, including action item tracking, meeting minutes, scope changes, risk tracking, prioritization, problem solving, escalation, and cross-functional support. Provide technical interface with the customer and gather product requirements. Review product designs for compliance with engineering principles, standards, and customer specifications. Provide technical input in product design, material selection, mold design, manufacturing, secondary operations, statistics, process validations, Quality Management System, and related industry areas. Ensure thorough development through mold, process, or assembly testing to support a robust manufacturing process. Drive DOE objectives, resolve testing issues, and review validation reports and project summaries. Develop and gather documentation during project setup and development phases. Provide status updates to management on a regular basis. Manage Device Master Record (DMR) and PPAP to ensure internal documentation is up to date at Release to Manufacturing (RTM). Provide post-RTM internal support and resolve any new issues that arise. Control project scope and monitor customer PO coverage. Track team time and align with customer coverage. Support sales by providing technical expertise and identifying new opportunities with existing customers; support quoting as requested. Maintain a safe work environment by following all company safety policies and procedures. May mentor junior engineers and support their career development; may advocate for the team and align goals with site objectives; conduct regular one-on-one meetings to ensure alignment on program and personal goals. Regular on-site attendance and professionalism are required. Perform other duties as assigned. Essential Qualifications
Bachelor of Science in Engineering, preferably Plastics. Minimum seven (7) years’ experience, preferably in contact manufacturing within the Plastics Injection Molding Industry. Ability to multi-task, stay organized, and manage time effectively. Excellent written and verbal communication skills for sensitive and confidential situations. Strong technical and proposal writing skills; solid presentation and computer proficiency. Ability to exercise sound judgment in problem solving. Working knowledge of 3D CAD software, Microsoft Office Suite, and ERP systems (Solidworks and IQMS preferred). PMI Certification is desirable. English proficiency in reading, writing, and communication. ADA Requirements
Stand, walk, bend, squat, twist, reach or move frequently. Occasional repetitive motion and grasping; occasional climbing to reach areas on machines or racks. Lift, move, or transfer up to 50 lbs occasionally; >20 lbs frequently. Typically sits and uses a computer; exposure to typical machine shop hazards which may require respiratory protection. Ability to travel up to 25% of the time as needed. What SMC has to offer
Clean, climate-controlled environment Stable schedule Paid holidays and PTO Health, dental, and vision insurance 401(k) retirement savings Life and disability insurance Promotional opportunities Training and career growth programs Amazing co-workers Tuition reimbursement Employee Assistance Program SMC Ltd. is an equal opportunity employer. M/F/D/V; this organization uses E-Verify. Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments. #IND
#J-18808-Ljbffr