Program Manager – CMO Medical Device
Our client has engaged us to help them find someone ready to step away from simply managing projects and is attracted to the challenges of managing the entire Program. This is one of those management roles where you don’t have direct reports so your abilities to persuade and elicit cooperation will be vital to your success.
You need to be highly technical as this is a CMO; have demonstrable experience creating and tracking complete program plans; maintain all of the requisite reports of a regulated business and regularly communicate to a variety of stakeholders. From Product Development to a successful Manufacturing Transfer your leadership and methods skills will be challenged every day.
The list of acronyms you need to be knowledgeable in is almost endless but includes IQ/OQ/PQ, (P)FMEA, SPC, V&V, and DOE just to name a few. You’ll be the client’s face to the customer as well as being the champion for their products internally. Still interested? Read on,
- Program file setup and maintenance (from Scope to Cost Control) using tools like MS Project
- Cross-Functional leadership of internal and external resources; coordinating the engineering projects via scheduling, tracking, and including engineering builds
- Understands early adopter feedback (Minimum Viable Product) as a critical component of development through the V&V phase of the Program
- Experienced with Vendor selection, Relationship and Supply Chain development
- Understands the critical nature of material specification and has developed BOM’s
- Implements DFMA as intrinsic to the Program through and including sterile packaging and shipping
- Appropriately applies ISO 14971
- Supports Test Method development
- May provide CAD support for drafting, tooling and fixture design
- Responsible for the smooth and effective transition to manufacturing with Validation documents, Line set-up and Training including development of procedures and support of Maintenance
- Actively engages with RA/QA to ensure compliance to FDA and ISO regulations
- May participate in quoting of new business opportunities
- BS in an engineering discipline with cross-disciplinary know-how highly desirable
- At least 5 years of demonstrable Project Management experience
- Experience in the Medical Device industry preferred
- Experience in a Contract Manufacturing (CMO) environment preferred
- Strong computer skills including the MS Office Suite, CAD (SolidWorks), MS Project, and Statistical software (Minitab)
- Six Sigma Green Belt cert
- Illustrated skills in manufacturing process flow, layout, assembly, and capital such as heat sealing, RF welding, adhesive dispensing, cutting/punching of thermoplastics, and inspection/test equip.
- Experience with electro-mechanical devices & equipment