R&D Program Manager

Position Summary
The Program Manager for Infusion Consumables R&D department for the Vascular Access, Sharps safety and Pain Management business units. The Program Manager is responsible for leading projects, with the support of an established Core Team and Program Managers, through the medical device product life cycle of development, qualification, manufacturing, and commercial release process.

Essential Duties & Responsibilities
Provide Program and Technical leadership for device development.
Develop, maintain, and document development plans through product development cycle.
Drive accountability in the position and within the cross functional team.
Identify resources needs, costs, program schedule, key milestones, scope, and report the progress to the established plan.
Lead teams to process improvements to enable effective decisions and outcomes.
Comply with design control process and meet Quality Management System requirements.
Manage program budget: functional expenses, capital requests, and forecasts.
Prepare and report program technical performance to different levels of organization including senior leadership.
Communicate with external partners to meet program goals.

Education and Experience
Bachelor's degree in in Engineering, Biological Sciences, Business or related fields from an accredited college or university is required
10 years of experience in product development leading multi-site global programs
Experience in the medical device or other regulated industry with equivalent design controls
High volume injection molding experience is preferred.
PMP Certification
Agile Certified Practitioner (ACP) a Plus

Knowledge, Skills & Qualifications
Demonstrated experience in leading and managing cross-functional multi-site teams to achieve program objectives in a matrix organization.
Ability to lead direct and indirect team members and enabling them to grow.
Experience in functional areas: High Volume Medical device consumables Development, Quality, Medical, Commercial, Manufacturing Operations, Procurement, and Regulatory is preferred.
Ability to evaluate and escalate changes that significantly impact the scope, timeline, or business goals or the program.
Familiar with FDA and MDR regulatory submissions and activities that lead to successful outcomes.
Show history of influencing technical teams, driving efficient decision making, and leading team through complex problem solving.
Use of metrics as indicators of potential roadblocks, risks, and issues which could block successful achievement of the program goals.
Self-directed with good interpersonal and communication skills to break down complex issues and process into clear actions.
Advanced knowledge and hands-on experience with MS Office and MS Project.

Nesco Resource and affiliates (Lehigh G.I.T Inc, and Callos Resource, LLC) is an equal employment opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status, or any other legally protected characteristics with respect to employment opportunities.