Program Manager

Program Manager

Company: Omega Plastics Inc

Primary Location: 24401 Capital Blvd, Clinton Township, MI 48036 USA

Employment Type: Salaried | Full-Time

Function: Manufacturing Production / Distribution

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Main Duties & Responsibilities

Position Summary:
This position provides overall Program Management responsibility for assigned major projects contributing to top-line business growth. This includes leading initiatives involving a Contract Design Manufacturer (CDM) for medical devices and tooling, ensuring seamless collaboration and execution of design, development, and manufacturing processes. Additional responsibilities include managing product changes, cost savings, and capacity expansion initiatives. The role requires strong leadership in working with cross-functional teams to navigate roadblocks and ensure project success. A demonstrated ability to influence across functional areas and coordinate both external and internal resources is essential, along with a proven track record of successfully leading and delivering large, complex projects. The successful candidate will exemplify best-in-class program management practices.

Essential Duties & Responsibilities:

• Apply fundamental, sound program management techniques and workflow processes when executing assigned projects, particularly those involving a CDM for medical devices and tooling.
• Develop and maintain project plans using MS Project and WBS structures, clearly outlining objectives, timelines, and risks, while adapting to evolving project requirements.
• Oversee communication planning, project risk assessment, and change management strategies, ensuring alignment with both internal stakeholders and external manufacturing partners.
• Facilitate effective team and client meetings, fostering strong relationships with CDM partners to drive project milestones and quality outcomes.
• Resolve and/or escalate issues in a timely fashion, particularly those impacting design transfer, regulatory compliance, and production timelines.
• Communicate effectively with project teams to identify needs and evaluate alternative business solutions.
• Ensure compliance with FDA regulations and ISO 13485 standards for medical device manufacturing, maintaining proper documentation of project activities.
• Aid in the development and implementation of Program Management guidelines and processes, incorporating best practices for working with external manufacturers.
• Support training events on execution processes to improve internal capabilities in managing CDM relationships.
• Act as a subject matter expert (SME) for program management, particularly in the integration of contract manufacturing partners into development pipelines.
• Periodic travel may be required to visit CDM facilities, suppliers, and stakeholders.

Qualifications

• Bachelor’s degree in business, engineering, medical technology, or a related discipline.
• Minimum 5 years’ experience as a project manager delivering medium to large, complex technical projects, preferably in medical devices, contract manufacturing, or regulated industries.
• Experience managing CDM relationships with a focus on product development, tooling, and commercialization.
• Strong verbal, written, and interpersonal skills, with the ability to build trust and foster collaboration across teams.
• Proven track record of successfully executing complex projects on time and within budget, with a focus on medical devices and precision tooling.
• Advanced proficiency in Microsoft Office, MS Project, and project visualization tools, with the ability to generate graphs, presentations, and reports.