Job Description
Join a company with over 70 years of expertise, family friendly environment and career growth.
Our client, a leading manufacturer of injection molding and medical devices, is seeking a permanent an R&D Project Manager to join their growing team in Charlotte.
Key Responsibilities:
- Customer Satisfaction: Prepare and support product development teams to ensure customer satisfaction with the outcome and deliverables of assigned projects. Support communication with the customer to resolve any issues and report project status. Escalate issues as needed for leadership support.
- Resource Management: Assign team members to projects based on allocated budget and project requirements. Balance workloads within the team and coordinate activities to achieve project goals. Work cross-functionally with other departments to ensure adequate resources are available.
- Training and Development: Mentor and guide staff on individual projects and career development through regular meetings and performance reviews. Train staff to collaborate with outside vendors to source materials, components, and processing. Manage the Team's hands-on product and process development of catheter, implant, and other disposable products.
- Financial Management: Support achievement of department financial objectives by managing costs and revenues to achieve profitability goals. Review and approve project invoices.
- Technical Support: Work with technical lead to provide technical support and troubleshooting for product development and project management. Supervise the preparation of documentation to support the quality system for design functions (project plans, concept documents, FMEA, design input, test results, drawings, etc.).
- Quality Assurance: Supervise development teams to ensure design and development practices are compliant with QMS & applicable regulatory requirements.
- Sales Support: Participate in the project quotation process by generating and/or reviewing project budgets and timelines.
- Data Analysis: Utilize data analytics to support efforts to achieve department KPIs and company objectives. Prepare regular reports and presentations for senior management.
- Continuous Improvement: Recommend and support improvements to SOPs/QMS, business practices, technologies, and other opportunities that improve the quality and consistency of services/products provided to customers while achieving business objectives.
Qualifications:
- Education: BS or MS in Engineering is required (Biomedical or Mechanical is preferred).
- Experience: Minimum of 8 years of experience in medical device development, 10+ years preferred. Previous supervisory and/or management experience in the medical device field preferred. US and International Regulatory requirements, quality management systems requirements, and varied medical device applications experience are highly preferred for understanding project requirements.
- Technical Skills: Technical skills must include disposable device design and development background, materials knowledge, and prototyping. Experience with project and/or program management of medical devices.
- Problem-Solving: Excellent analytical and problem-solving skills, with the ability to identify root causes and implement effective solutions.
- Communication: Strong communication and interpersonal skills, with the ability to work effectively in a multicultural and cross-functional team environment.
- Travel: May require occasional domestic and international travel.
Benefits:
- Competitive salary and performance-based bonuses
- Comprehensive health, dental, and vision insurance
- Retirement savings plan with company match
- Paid time off and holidays
- Professional development and training opportunities
Job Tags
Permanent employment,