NPI Program Manager, International Programs

Position summary

The Program Manager is responsible for facilitating all aspects of the engineering projects for assigned customers from the early prototyping stage all the way into production. This position acts as the customer advocate and leads customer programs that ensures compliance to customer, industry, and company requirements and standards.

Essential Job Functions

• Administer and manage customer projects to develop and meet requirements, scope, schedule, budget, and quality expectations
• Build and maintain positive working relationships with internal and external customers that encourages two-way communication
• Create a sense of urgency and leads customer programs through the organization in a timely manner
• Facilitate identification of risks to programs during both the Proposal/Quote phase as well as the Program realization phase
• Work with internal and external customers to put in place risk mitigation strategies and parallel paths as necessary
• Understand manufacturing capabilities and capacity of the organization
• Achieve a high-level understanding of manufacturing and engineering processes that relate to the medical device industry
• Facilitate quotations and proposals for company products and services in a timely fashion that put the business in a position to win new programs
• Work closely with the manufacturing engineers, quality engineers and operations teams to ensure gross margin targets are maintained or exceeded
• Lead discussions with customers and internal teams on designs, troubleshooting and finding cost effective solutions
• Manage/facilitate the transfer to production with internal NPD/NPI teams

• Understand customer needs and the core business markets we serve
• Ensure business systems are implemented, maintained, and functioning properly
• Participate in required company meetings

• Proactively communicate with customers on a routine basis and provide project plans, timelines, and milestones that meet their expectations
• Work closely with Engineering, Operations/Production, Supply Chain, Scheduling, and Quality to meet or beat customer delivery dates and On-Time-Delivery (OTD) performance
• Work with Quality to facilitate customer required audits
• Supports S&OP planning for assigned programs and customers
• Communicate and deliver employee communication tools for job performance to include annual performance goals, employee recognition, training, and development, coaching and counseling

• Support and comply with the company Quality System, ISO, and medical device requirements
• Read, understand, and follow work instructions and standard work
• Effectively partner with internal businesses and functional teams to facilitate a collaborative spirit throughout programs and projects.
• Ensure business systems are implemented, maintained, and functioning properly
• Participate in required company meetings
• Maintain an organized work area
• Participate in the Operational Excellence Program
• Complete all other work duties as assigned
• Ability to work in a manufacturing environment

Minimum Requirements, Education & Experience (incl. KSA's and certifications)

• Associate degree in related field
• 6+ years of experience in medical device assembly design or manufacturing as a project or engineering leader
• Extensive experience with medical device contract manufacturing
• Experience managing numerous projects simultaneously using appropriate software tools (i.e. Excel or Microsoft Project) and professionally communicating project status to customers
• Knowledge of ISO 13485, and FDA regulations
• Proven interpersonal and leadership skills to manage cross-functional teams with accountability to program timelines
• Demonstrated ability to consistently achieve short and long-term business results
• Facilitate root cause analysis discussions with team members to support the identification of underlying issues and promote collaborative problem-solving
• Knowledge and experience with Lean Manufacturing preferred
• Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher)
• Clear and effective verbal and written communication skills

Desirable Criteria & Qualifications

• Bachelor's Degree in Engineering
• PMP Certification
• Continuing Education; including participation in local chapters, associations, and/or organizations