SR ENGINEERING PROGRAM MANAGER
The Senior Engineering Program Manager is the management lead, inclusive of the full range of products. The scope of this roll spans the entire product life-cycle, from the R&D of concepts thru product development thru sustaining engineering for legacy devices. The candidate must have experience developing medical products in a quality medical system environment and be capable of working with the Engineering and Quality teams to implement efficient design control processes. Also, responsible for developing project plans, organizing the project teams, facilitating communications, monitoring project tasks, ensuring that anticipated target dates are met and ensuring that costs remain within budget. Communication and organization skills are essential traits due to the number of program interfaces and concurrent projects that need to be managed.
- Provide project management leadership to cross-functional teams, including external resources.
- Use a consistent project management and system development methodology, maintaining the accountability of all team members.
- Lead requirements gathering sessions with subject matter experts and ensure core requirements exist to meet program-specific objectives.
- Proactively identify and implement efficiency opportunities: analyze processes, recommend improvements, research potential technology solutions, gauge progress against performance metrics and be a catalyst for change.
- Conduct post project analysis to identify potential improvement in processes, ensure project goals were met, evaluate cost variances, analyze actual versus projected metrics and determine the overall efficiency of the project.
- Analytical and Management Skills: Capable of quantifying project deliverables into a clear and tractable plan.
- Quality Systems: Understanding of the design control deliverables required of 21CFR Part 820 FDA Quality Systems Regulations and ISO 13485
Experience and Qualifications
- Minimum of a Bachelor’s degree in Engineering and/or Management
- Minimum of 10 years product development experience
- Minimum 3 years of project management experience
- PMP certification preferred
- Experience with product development from concept to commercialization
- Consumer and medical product experience preferred
- Strong leadership qualities and with the ability to work independently
- Excellent organizational, interpersonal, communication and problem-solving skills
- Strong Microsoft Office skills; Advanced Excel experience preferred