The Program Manager is accountable for the overall program success throughout the full product lifecycle, from proposal through manufacturing NPI (New Product Introduction) and full production, while maintaining strict compliance with the Cogmedix Quality System, 21 CFR 820, and ISO 13485. Success is measured by business metrics, audit results, and customer satisfaction.
Program Managers may be responsible for multiple Programs within one customer or multiple customers.
Principal point of contact with customer, responsible for building quality relationships with key stakeholders that result in a valued and trusted relationship, customer satisfaction, and continued strategic business expansion opportunities. This begins by early assignment of a Program Manager as the leader of the Customer Success Team.
Provide regular program status update reports to customers and senior management that highlights status against key milestones, issues, risks and mitigations impacting performance, schedule and cost.
Principal point of contact with senior management, responsible for presenting regular concise program status updates, and ensuring timely resolution to critical program issues.
Responsible for Program performance including NPI, process validation, schedules, milestones, materials management strategy, SO and WO aging, excess and obsolete material disposition, and quotation vs. manufacturing cost accuracy (gross margin). Responsible for ensuring status reports are thorough, accurate, and completed at specified intervals.
Responsible for the change management process with the customer to ensure appropriate and timely coverage for additional efforts, out of scope activities, material disposition, and communicating impacts internally and/or to the customer (e.g., financial, inventory, WIP, open supplier orders, etc.).
Responsible for coordinating with peers, Quality, Manufacturing Operations, and Supply Chain for identifying resource needs and allocation, and resolving any identified conflicts that may impact program success.
Responsible for customer contract adherence and Purchase Order management.
Responsible for defining and maintaining customer business needs and expectations.
Own customer relationship management, including risk management and conflict resolution.
Support growth of the business by supporting New Business Development opportunities and identifying new opportunities at existing customers, including Engineering Service projects.
Responsible for overseeing training, performance, and growth of Associate Project Managers and Project Managers.
Program Managers collaborate with Executive VP/GM, Director of Program Operations and the Senior Vice President of Corporate Quality and Compliance with regard to Manufacturing and Quality Agreement reviews as required.
Responsible for initiating actions to prevent nonconformance and recommends or provide solutions through designated channels.
May have other duties and responsibilities as required.
Commitment to compliance adherence.
Positive attitude, self-motivator, tenacious follow up, and excellent organization skills.
Superior customer service attitude and communication skills.
Associate’s or Bachelor’s degree preferred, preferably in a technical discipline. Applicable professional experience may be considered in lieu of certain educational requirements.
5+ years Project or Program Management preferred. Professional experience in engineering, manufacturing, supply chain, quality engineering or other roles in the medical device industry may be considered in lieu of direct project management experience.
Experience in an ISO 13485 and FDA cGMP compliant environment highly desirable.
3+ years’ experience with an FDA regulated medical device manufacturer preferred.
Strong interpersonal skills; must be capable of effectively establishing professional rapport with internal personnel and customers.
Should be strong in Microsoft products including Word, Excel, PowerPoint. Experience with Visio and Project preferred.
Must be able to climb stairs and lift up to 30 lbs.