Program Manager (ISO 13485)

About the Role

This position is responsible for performing engineering and program management tasks to integrate new products from concept to manufacturing in a contract manufacturing environment. The role involves reviewing drawings, visualizing product details, understanding manufacturing methods and process flows, and estimating time, cost, and resources required for production. The ideal candidate has experience with medical industry manufacturing processes, quality planning, and proven manufacturing experience in an injection molding environment. This position serves as the key engineering point of contact for new and ongoing sustaining projects with face-to-face customer account responsibility.

Responsibilities

• Lead the project launch and integration of assigned new programs requiring engineering functions both internally and externally.
• Foster cooperation across cross-functional departments to build a synergistic team and achieve project goals and deliverables.
• Develop and maintain professional face-to-face engineering relationships with customers to ensure timely delivery to market.
• Review drawing requirements to identify special processes, manufacturing concerns, and ensure alignment with the company’s manufacturing capabilities.
• Facilitate quoting of costs and services outside the original project scope.
• Create bills of materials and engineering documents.
• Procure new program materials or assets as required by the project.
• Identify innovations or concepts to improve costs and operational efficiencies.
• Coordinate projects across multiple manufacturing locations, with 5-10% travel required.
• Utilize estimating tools to calculate bill of material requirements, manufacturing time/cost, and prepare final proposals for review and deployment.
• Review estimating processes and suggest cost improvements to benefit EBITDA profitability.
• Apply working knowledge of quality planning elements for successful deployment of IQ, OQ, PQ, and medical protocols.
• Use MS PowerPoint to generate presentations and proposals for internal and external teams.
• Defend company processes, profitability, and reputation with leadership and resolve.

Requirements

• College degree in BS Engineering or equivalent combination of education and experience.
• Minimum of 5 years of experience in an injection molding environment.
• Experience working in an ISO 9001 environment; knowledge of ISO 13485 and FDA CFR 21 820 quality standards is a plus.
• PMP Certification preferred.

Skills

• Analytical Skills/Organization: Strong analytical skills with attention to detail, exceptional organizational and multi-tasking abilities, and the ability to manage and motivate cross-functional teams.
• Manufacturing Familiarity: Well-versed in value stream analysis for manufacturing methods and equipment, including molding, secondary operations, engineering consulting, validation, and assembly processes.
• Plastics: Previous hands-on molding experience is required.
• Professional Demeanor and Integrity: Self-starter who works with minimal supervision, demonstrates accountability, and upholds integrity and ethical business practices. Must be thorough, quality-focused, and able to report program costs professionally.
• Applications Skills: Proficient in MS Word, Excel, Outlook, PowerPoint, and MS Projects; Minitab is a plus.
• Production and Processing: Knowledge of raw materials, production processes, quality control, and cost optimization techniques.
• Time Management: Ability to manage personal time and respect the time of cross-functional team members.
• Critical Thinking: Use logic, reasoning, and data to identify strengths and weaknesses of solutions, and apply problem-solving methods and risk assessments.
• Judgment and Decision Making: Evaluate costs and benefits of potential actions to choose the most appropriate path forward.
• Interpersonal Relationships: Develop and maintain constructive, cooperative, and long-term working relationships with colleagues, suppliers, and customers.
• Dependability: Consistently punctual and reliable, follows instructions, responds to management direction, and seeks feedback to improve performance. Strong verbal and written communication, organizational, and leadership skills.
• CAD: Ability to interpret complex industry drawings, terminology, and process sheets. Proven ability to understand and interpret 2D drawings, visualize product details, and apply GD&T knowledge. CAD experience is preferred but not required.