Medical Device Program Manager Jobs in Kenosha, WI

Operations Manager

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Position Summary:

We are seeking an experienced and results-driven Operations Manager to oversee the operations of our plastic injection molding facility specializing in the production of medical device components. This position is responsible for managing the overall production function, while collaborating with program management, quality assurance, engineering, maintenance, and supply chain functions to ensure compliance with ISO 13485, FDA regulations, and internal quality standards. The ideal candidate will possess strong leadership skills, deep manufacturing knowledge, and a commitment to continuous improvement and regulatory compliance.

Key Responsibilities:

·       Oversee daily operations of injection molding production to meet or exceed safety, quality, delivery, and cost goals.

·       Ensure compliance with all regulatory and quality system requirements (e.g., ISO 13485, FDA cGMP).

·       Develop and implement operational policies, procedures, and best practices.

·       Collaborates with management, production, and the commercial team to evaluate manufacturing feasibility leading to quote compilation for new and existing products.

·       Forecasts operating costs of the department and directs preparation of budget requests.

·       Partners with team and management in the development of the strategic plan and Annual Operating Plan (AOP) for the function.

·       Reviews and establishes material, equipment, and manpower resource requirements.

·       Prioritizes production schedules based on product introduction, equipment efficiency, and materials supply to meet customer requirements.

·       Coordinates production activities with other functional groups, such as planning and distribution.

·       Selects and develops personnel to ensure the efficient operation of the production function.

·       Accountable for controlling manufacturing operations, and ensuring that production quality and cost targets are met.

·       Develop customer relationships to be the partner of choice.

·       Plan, organize and lead production ramps to meet customer demand increases.

·       Drive continuous improvement initiatives using Lean, 5S, KAIZEN and other methodologies.

·       Explores technology trends and market demand to plan projects.

·       Collaborate with Engineering on design for manufacturability (DFM), mold validation, and new product introduction (NPI).

·       Manage staffing, training, performance reviews, and development of team members

·       Monitor KPIs and use data to identify areas for improvement in efficiency, scrap reduction, and downtime.

·       Oversee plant scheduling, capacity planning, and resource allocation.

·       Ensure proper preventive maintenance and readiness of molding equipment and tooling.

·       Coordinate with supply chain and procurement teams to ensure material availability and inventory optimization.

Qualifications:

Required:

·       Bachelor’s degree in Engineering, Operations Management, or related field.

·       Minimum of 7 years’ experience in a manufacturing leadership role, with at least 5 years in plastic injection molding.

·       Strong knowledge of medical device manufacturing standards and regulations (ISO 13485, FDA 21 CFR Part 820).

·       Demonstrated experience with Lean Manufacturing and/or Six Sigma methodologies.

·       Strong leadership, problem-solving, and organizational skills.

·       Excellent communication and interpersonal abilities.

·       Demonstrates detailed expertise in very complex functional/technical area or broad breadth of knowledge in multiple areas; understands the strategic impact of the function across sites.

·       Demonstrates advanced people and/or process management skills as well as customer (external and internal) relationship skills.

·       Demonstrates knowledge of multiple functional technologies/processes, industries or functions, and understanding of interdependencies of such processes at the site.

·       To perform the major job responsibilities the use of the following tools may be required: Office Skills: telephones, word processing, spreadsheet (PC), presentation, and database software.

Preferred:

·       Certification in Six Sigma (Green Belt or higher), PMP, or Lean.

·       Experience with Class I, II, or III medical device manufacturing.

·       Scientific Injection molding process knowledge

Working knowledge of molds and tool maintenance