Cogmedix

DESCRIPTION:

The Engineering Program Manager is accountable for the overall program success through the full customer engagement life-cycle, from requirements definition, proposal offering, contract negotiations, executable plan for product development, validation/qualification test, final acceptance, all in support of the design control process, 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.  The Engineering Program Manager will be responsible for multiple Programs, and Programs may consist of single or multiple Projects within the Program, largely dependent upon size and complexity.  This role is responsible for maintaining customer and internal dashboards and time management/audit of the engineering staff.

RESPONSIBILITIES:

  • The Engineering Program Manager will be responsible for multiple Programs within one customer or multiple customers.
  • Proficient at managing and mentoring various resources and processes that provide design, prototyping, documentation, validation/qualification services to achieve initial product release.
  • 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 the Engineering 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.
  • Responsible for entering and maintaining Project information in PLM and ERP systems.
  • Provide summary of regular financial updates on Engineering Services programs.
  • 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 design control process, schedules, milestones, materials management strategy, SO and WO generation, SO and WO aging, excess and obsolete material disposition, and quotation. 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 other PMs, Project Engineers and VP of Engineering for identifying resource needs and allocation, and resolving any identified conflicts that may impact program success.
  • Responsible for coordinating with peers, Engineering Services, Quality, Manufacturing Operations, and Supply Chain for identifying resource needs and allocation, and resolving any identified conflicts that may impact program success.
  • Responsible for space/facility planning requirements, 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 Engineering Services, New Business Development opportunities and identifying new engineering opportunities at existing customers, including manufacturing opportunities.
  • Collaborate with Executive VP/GM, SVP of Engineering, SVP of Sales and Program Management, and the Senior Vice President of Corporate Quality and Compliance with regard to Engineering and Quality Agreement reviews as required.
  • Responsible for initiating actions to prevent nonconformance and recommends or provide solutions through designated channels.
  • Leads phase closeout reviews for analysis of delivery against plan. Generate recommendations to be considered for incorporation into next phase of activity for continuing improvement in performance against target metrics.
  • Responsible for structuring and maintenance of the Design History File (DHF) which contains all documentation which provides a design history of the project activities.
  • May have other duties and responsibilities as required.

ESSENTIAL REQUIREMENTS:

  • Commitment to compliance adherence.
  • Positive attitude, self-motivator, tenacious follow up, and excellent organization skills.
  • Superior customer service attitude and communication skills.
  • Bachelor’s degree in engineering/related 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 required.
  • Design Control experience is required.
  • 3+ years’ experience with an FDA regulated medical device engineering preferred.
  • Strong interpersonal skills; must be capable of effectively establishing professional rapport with internal personnel and customers.
  • Excellent negotiation, problem solving, and written and oral communication skills, including experience presenting to customers and internal senior management.
  • Must be strong in Microsoft products including Word, Excel, PowerPoint Visio and Project.
  • PMP certification a plus, but not required.
  • Experience with ERP and PLM systems is a plus, with Epicor and Omnify experience beneficial.
  • Generally works in an office environment, but may occasionally be required to perform job duties outside of the typical office setting. Occasional travel required.
  • Must be able to climb stairs and lift up to 30 lbs.