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.
Responsibilities
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
Qualifications
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
Attention to detail
Organizational skills
Ability to work in a fast-paced team environment
Ability to prioritize and multitask
Desirable Criteria & Qualifications
Bachelor's Degree in Engineering
PMP Certification
Continuing Education; including participation in local chapters, associations, and/or organizations
Physical & Environmental Demands
Cretex Companies use cutting oils, solvents, and other chemicals in the manufacturing process. Testing is conducted on a periodic basis to ensure that all chemicals are kept well below the OSHA permissible exposure levels.
