Director of Product Development - Medical Devices

Creating and managing project plans (project scope, timeline, and budget) to satisfy milestones and deadlines with required actions. Act as the subject matter expert for new products as it relates to product development, including but not limited to design control management and transfer process, device history management, change control, verification, validation, and translation of technical information.

Responsible for :

• Creating, maintaining, and updating project plans that will drive schedule as well as resources management (internal and external).
• Assisting leadership and cross functional teams to drive portfolio of activities around product development to accelerate product launch.
• Guiding and providing leadership and expertise to technical teams.
• Overseeing product development activities to meet business and customer needs.
• Monitoring and communicating project status, plans, issues, timelines, action items, and budgets internally and externally. Recommend and implement corrective actions.
• Document activities to ensure that newly developed product meets the product specifications and all applicable requirements of the FDA, ISO 13485 and / or MDD / MDR.
• Manage and conduct product development activities with a focus toward 510(k) clearance / CE Mark.
• Develop protocols and reports in collaboration with pilot manufacturing.
• Assist in validation of applicable metrology equipment to meet all regulatory and quality requirements.
• As SME provide key technical input and information for root cause analysis and investigation of product-related issues.
• Prepare and present technical product analysis for use by customers (internal and external).
• Ensure all activities are conducted in adherence to applicable national / international regulations, guidelines, company policy, SOPs and industry standards.
• Serve as point person for outside vendors that are generating data for 51Ok / CE submissions. May be required to identify the topics / subject areas (OMS, Regulatory, R&D, Manufacturing, and Marketing) that may need further input from subject matter experts. Facilitate these interactions and prepare materials to ensure these communications are efficient and effective.
• Strong background with design controls, design verification and validation, and project management skills.

Competencies and Educational Requirements

Education : Bachelor’s Degree in Mechanical, Biomedical Engineering, or Sciences Field

Experience : Minimum 15 years of professional experience in Project Management and Medical Product Development.

Communication skills : Bilingual (English and Spanish). Excellent written and verbal

communication skills are required and must be able to write clear reports, proposals, etc., and efficiently discuss the same with other scientists, engineers, and customers.

Technical Proficiencies : Project Management Experience, ISO 13485, MDD / MDR, Design Controls, Design Verification & Validation, Microsoft Programs, Previous experience in start-ups.

Judgment and Decision Making : Ability to take initiative and effectively adapt to changes. Demonstrated experience as a self-starter and a fast learner; must work efficiently responding to changing priorities with minimal disruption, able to work independently and within a team; must have excellent problem-solving skills, analytical skills, research skills and attention to details. Must be able to consistently meet deadlines, manage projects across several collaborators and handle multiple projects simultaneously.