Program Manager; ISO

This position is responsible for performing engineering and program management tasks to integrate new products from concept to manufacturing in a contract manufacturing environment. Activities include reviewing drawings, visualizing the product detail, understanding the manufacturing methods and process flows required to produce the item or assembly, and estimating the appropriate time, cost, and resources required to prepare and perform each process.

The ideal candidate has experience with medical industry manufacturing processes, quality planning experience, and proven manufacturing experience in an injection molding environment. This position will be the key engineering point of contact for several new and ongoing sustaining projects with face‑to‑face customer account responsibility.

• Responsible for Project Launch and Integration of assigned new programs that require engineering related functions internally and externally.
• The ability to garner the cooperation of cross‑functional departments to develop a synergistic team to attain desired project goals and deliverables.
• Building a professional face‑to‑face engineering relationship with customers as a program is developed to ensure timely delivery to market.
• Utilizing manufacturing experience to review drawing requirements and identify special requirements/processes or possible manufacturing concerns to determine the proposed project is aligned within the company’s manufacturing capabilities and product scope.
• Facilitate quoting of costs and/or services outside of original project scope.
• Creating bills of materials and engineering documents.
• Procurement of new program materials or assets relative to the project requirements.
• Identifying new innovations or concepts to improve costs and operational efficiencies.
• Coordinate the projects across multiple manufacturing locations; 5‑10% travel may be required.
• Utilizing estimating tools to create/calculate bill of material requirements, manufacturing time/cost, and prepare final proposals for review and project deployment.
• Perform reviews for estimating processes and cost suggestions for improvements that benefit EBITDA profitability for continued growth of the company.
• Will have a working knowledge of Quality Planning Elements for successful deployment for IQ, OQ, PQ, Medical protocols.
• Will have proficiency for utilizing MS PowerPoint for generating presentations and proposals to internal and external teams.
• Will possess the leadership and resolve to defend company processes, profitability, and sterling reputation.

• Must be able to interact with customers in an open and honest manner and create positive relationships.
• Knowledge of validation and production processes in contract manufacturing.
• Must be able to manage multiple customers and multiple projects simultaneously.

• Analytical Skills/Organization - Strong analytical skills with attention to detail. Exceptional organizational and multi‑tasking skills. Highly organized and can professionally manage and motivate internal cross‑functional teams and clients well.
• Manufacturing Familiarity - Must be well versed in value stream analysis for numerous manufacturing methods and equipment including molding, secondary operations, engineering consulting time, validation, and various added‑value assembly processes.
• Plastics - Previous hands‑on molding experience is required.
• Professional Demeanor and Integrity - Be a self‑starter who can work with minimal supervision with the expected accountability. The candidate works with integrity and ethical business practices. Must be thorough in completing tasks and focused on quality output. Will be responsible for consolidating, organizing, and reporting the program costs face‑to‑face with the client with a professional delivery. Team player with a positive, encouraging demeanor.
• Applications Skills - Knowledge of computers and relevant software applications. Proficient in MS Word, Excel, MS Outlook, PowerPoint, MS Projects, Minitab a plus.
• Production and Processing - Knowledge of raw materials, production processes, quality control, costs,…