Program Manager (ISO 13485)

Program Manager (ISO 13485) 4501 East Wall Street, Ontario, CA 91761 $100,000

• $140,000 a year
• Full-time $100,000
• $140,000 a year
• Full-time 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.

Essential Job Functions and Responsibilities :

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 costs 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

Core Competencies:

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 Knowledge, Skills, and Abilities 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 a 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 and MS Projects, Minitab a plus Production and Processing
• Knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture and distribution of goods Time Management
• Managing one's own time and being sensitive for the time of cross-functional team members Critical Thinking
• Using logic, reasoning, data based empirical evidence to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problem solving. Must be able to employ problem solving methods, techniques and risk assessments to ensure successful product deployment Judgment and Decision Making
• Considering the relative costs and benefits of potential actions to choose the most appropriate path forward. Establishing and Maintaining Interpersonal Relationships
• Developing constructive and cooperative sustained long-term working relationships with internal colleagues and external sources to include suppliers and customers Dependability —the individual is consistently at work and on time, follows instructions, responds to management direction and solicits feedback to improve performance.

Must possess Strong Verbal and Written communication, organizational, and leadership skills. Ability to enforce company policy and values CAD

• Ability to interpret and understand complex industry drawings, terminology, and process sheets.

Demonstrated ability to understand and interpret 2D drawings, visualize the product in detail, create a mental picture of the manufacturing methods and steps required to produce the item or assembly within project budgets and timeline constraints and possess proven working knowledge of GD & T for 2D mechanical drawings, CAD experience preferred but not required Education and/or

Experience :

College degree BS Engineering or equivalent combination of education and experience. Minimum of 5 years of experience in injection molding environment. Experience working in an

ISO 9001

environment; knowledge of ISO 13485, and

FDA CFR 21 820

quality standards a plus. Recognized with PMP Certification Preferred