Program Manager chez 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.
• Previous experience working within the pharmaceutical or medical device industry is required, with a strong understanding of industry standards, regulations, and compliance expectations.
• Work with internal and external resources to research, design, and develop all of the necessary elements of the program including, but not limited to molds, tooling, processes, automation, fixtures, EOAT, secondary equipment, etc. 
• Effective use of personal and team, and organizational communication.  As the primary interface good communication skills and responsiveness are required.
• Develop program timelines that support our quoted lead-times, and incorporate the customer requirements for validation, pilot builds, and approval.   
• Manage program to ensure that we meet the customer deliverables and complete a successful development so that we meet the quality and financial requirements of the program.  
• Deploy good program management techniques with internal and external teams – Action item lists, meeting minutes, scope change management, risk tracking, strong communication skills, setting priorities, problem solving techniques, proper escalation activities, and seeking other assistance as required.
• Be the primary technical interface with customer.  
• Gather product requirements from the customer.   
• Review product design for compliance with engineering principles, engineering standards and customer requirements and specifications.  
• Provide technical support and input in the areas of product design, material selection, mold design, manufacturing, secondary operations, statistics, process validations, Quality Management System, Quality System Regulation and other areas related to our industry.  
• Ensure that mold, process, or assembly testing is performed in a manner that will give us a thorough development, and a robust manufacturing process.   
• Drive team to determine test and DOE objectives. Resolve issues that are found during testing. Review reports as related to the project including validation reports and summaries.
• Develop and gather all the necessary documentation during the project set-up and development phases.         
• Prepare and provide status reviews to management on a regular basis.
• Manage the development of the Device Master Record (DMR) and PPAP to ensure that internal documentation and systems are up to date at the time of the Release to Manufacturing (RTM). 
• Provide internal support for the project after RTM, and resolve any new issues that develop.
• Controlling program scope and keeping a good handle on PO coverage.
• Keeping track of team’s time and ensuring it is getting properly covered by customer.
• Support the sales effort by providing technical expertise and identifying potential new opportunities with existing customers.  Support the quoting phase of the project as requested.
• Responsible for maintaining a safe work environment by following all company safety policies and procedures.
• May be responsible for mentoring junior engineers and helping them define and grow within their own career paths.
• May be responsible for advocating for your team and ensuring that their performance and goals are lining up with site objectives on a yearly basis.
• May be responsible for holding consistent one-on-one conversations with your junior engineers 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 Degree in Engineering preferably Plastics.  
• A minimum of Seven (7) years’ experience, preferably in the contact manufacturing within the Plastics Injection Molding Industry.
• Capable of Multi-tasking, organized, excellent time management skills.
• Must have excellent written and verbal communication skills to handle sensitive and confidential situations.  
• Strong technical and proposal writing skills.  
• Must have strong presentation skills and computer proficiency.
• Ability to exercise strong judgment in analyzing, evaluating and solving problems.
• Working knowledge of 3D CAD software, Microsoft Office Suite, and ERP Systems.  Preferably Solidworks and IQMS.
• Desired PMI Certification
• Ability to read, write and communicate in English.

 

 

ADA Requirements:

• Stand, walk, bend, squat, twist, reach or otherwise move frequently
• Occasional repetitive motion and grasping
• Occasional climbing to reach areas on machines or racks
• Lift, move or otherwise transfer up to 50 lbs. occasionally, >20 lbs. frequently
• Typically sits, grasps items or performs keyboarding for occasional operation of a computer
• Exposure to typical machine shop physical hazards which may require respiratory protection
• Ability to travel up to 25% of the time as needed

At SMC Ltd. we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job.  If your experience is close to what you see listed here, please still consider applying.  We know that our differences often can bring about innovation, excellence and meaningful work—therefore, people from all backgrounds are encouraged to apply to our positions.  Please let us know if you require reasonable accommodations during the interview process. 

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