Program Manager (Senior)
Our client is a successful Contract Manufacturing concern that supplies the Class III Medical Device space with unique products and services, taking advantage of their exceptional background in material science. This location is experiencing continued double-digit growth and they are looking for hands-on mechanical engineering skills that have been honed in preparation for a Project Management position.
What’s the upside? Where’s the opportunity? Contrary to the large corporate environment, this position will NOT pigeonhole you. You’ll be involved in the breadth of the process from customer discovery, to quality planning, to definition of testing requirements, to process development and implementation, to budget management, and cross-functional team leadership. You will be customer-facing and every day will bring new challenge. And you’ll get to see your results impact the business.
- In-depth, hands-on knowledge of program management, defining and implementing effective Stage-GateÒ decision-making frameworks with demonstrable tracking and reporting skills
- Full-breadth Program/Project Management from client definition to manufacturing implementation including budget, timelines/milestones, risk, resource requirement, and reporting
- Leads SME’s through personal expertise and ability to demonstrate credibility
- Manages multiple, simultaneous projects
- Customer facing during the entire project, confirming inputs, reporting test results and performance to schedule, adapting to changing needs, and confirming desired outputs
- Knows how to use appropriate, effective data in the construct of how to say no, balancing tact, negotiations skills and directness
- Demonstrable knowledge of tools like P&L, Cost Modeling, NPV, IRR and others that contribute to ensuring an effective sales price to profit margin for the client and the company
- Understands how to wend through a company’s organization to find the required business support at the appropriate time (e.g. Financial, Manufacturing, Quality, etc.)
- Ensures the implementation of ISO 13485 and FDA rigors, as required, to provide for Design Control requirements and achievement of Project Objectives
- Uses all the tools required in a regulated environment like V&V, IQ/OQ/PQ, DOE, SPC, Sampling Plans, Process Capability, etc.
- BS in a Technical Engineering discipline, other education or certifications that are highly valued include an MS and/or PMP
- Hands-on experience in a Medical Device environment whether at an OEM or with a highly successful Contract Manufacturer
- 10 years of experience where at least 3 are in a demonstrably successful PM role and includes management of DR’s and/or project teams
- Medical Device knowledge in one or more; Cardiovascular (e.g. stents, grafts, VC filters, etc.), CRM, or tissue scaffolding
- Knowledgeable in FDA & ISO regulated manufacturing including Design Control and Stage-GatingÒ
- Foundation Mechanical Engineering skills used daily, Materials Science, Biomedical Engineering and Bioscience knowledge a plus