Experience Requirements
-Working knowledge of manufacturing processes related to medical device manufacturing
-Ability to prioritize and work independently as a self-starter with strong proactive work ethics
-Experience with design controls, FDA regulation, GMP practices, and QSR requirements
-Ability to manage programs across multiple locations and project teams
-Proficient in Microsoft Office and Microsoft Project
-Good working knowledge of GD&T with proficiency in either Auto Cad or Solid Works
-Experience with Risk Analyst tools and procedures
-Proven track record in Leadership role and utilizing Project Management
-Demonstrated customer relations, presentation, problem solving, and negotiation skills
-Ability to influence across boundaries, drive collaboration, as well as a good change agent
-Must be well-organized, detail-oriented, with excellent oral and written communication skills
Qualification Requirements
-BS Mechanical Engineering, or the equivalent in a related field
- 10 years experience in Medical Device manufacturing
Preferred Qualifications
-Previous experience with sutures, textiles, and absorbables
Responsibilities
This positions responsibility is for new business, existing products, and interfacing with customers, vendors, and internal departments, all of which are essential to achieving our goal of on-time delivery and high quality products. Relies heavily on experience and judgment to plan and accomplish goals with minimal supervision.
ESSENTIAL DUTIES AND RESPONSIBILITES:
-Develop products, project plans, specify project goals, strategy, scheduling, risks, contingency plans, project deliverables, milestones, and allocation of resources
-Directs and coordinates activities of project personnel to ensure progress and within budget
-Review and prepares status reports, modifies schedules, and project plans as required
-Keeps management, customers, and others informed of project status and/or related issues
-Confers with project team to provide technical advice, root cause analysis, and resolve customer or project related problems; new materials, assembly or manufacturing processes
-Writing, monitoring, managing, and reviewing protocols, including verification and validation tests, ECN, SOP’s, BOM’s, drawings, and may include calculation and/or FMEA etc...as required to develop, support, or maintain technical documentation
-Apply design controls from initial customer requests throughout the product’s life cycle
-Determine product specifications/limitations and monitor results against technical specification
-Collaborates to develop quality assurance, testing, regulatory compliance, and quality plans
-Support manufacturing, marketing, and customer service; to interface customers & suppliers
-Address customer’s issues: improve performance, appearance, and impact on end-user
-Travel 15-20%
