Program Manager (ISO 13485)

Balda-C-Brewer; New York (NY); On-site; USD 90,000 - 130,000; Full time

Job summary

Balda-C-Brewer is seeking an experienced engineer/program manager to lead the launch and integration of new medical manufacturing programs. You will collaborate with engineering, manufacturing, and customer teams to ensure timely delivery and feasibility of processes and tooling.

The role requires 5+ years in injection molding, ISO 9001/13485 knowledge, and strong project management, with travel 5–10% to coordinate across locations and suppliers.

Qualifications

• College degree BS Engineering or equivalent combination of education and experience.
• Minimum of 5 years of experience in injection molding environment.
• Experience in ISO 9001 environment; knowledge of ISO 13485 and FDA CFR 21 820 quality standards a plus.
• PMP Certification preferred.
• Ability to coordinate cross-functional teams and manage multiple projects simultaneously.

Responsibilities

• Project Launch and Integration of assigned new programs across engineering and manufacturing.
• Coordinate projects across multiple manufacturing locations with 5-10% travel.
• Garnish cooperation of cross-functional departments to meet goals and deliverables.
• Create BOMs and engineering documents; assist in procurement of materials.
• Identify innovations to improve costs and operational efficiencies; support EBITDA growth.
• Interface with customers as a program is developed to ensure timely delivery.
• Review drawings and assess manufacturing methods and process flows for feasibility.

Skills

Project management

Cross-functional collaboration

Customer liaison

Analytical thinking

Time management

Leadership

Communication

Problem solving

Education

BS Engineering

Tools

CAD

Minitab

MS Word

MS Excel

MS Outlook

MS PowerPoint

MS Projects

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Full Time Professional Ontario, CA, US

23 days ago Requisition ID: 1121

Salary Range: $90,000.00 To $130,000.00 Annually

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